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36 jobs from X4 Group Ltd Next Page

Job Title Regulatory Affairs Specialist / Regulatory Associate Salary/rate £33000 - £38000/annum Location Hampshire, South East Job Number 120262117 Posted 25/05/2012 (16:58) Agency/Employer X4 Group Ltd Description Role: Regulatory Affairs Specialist / Regulatory Associate / Senior RA Specialist Salary: £33,000 - £38,000 Location: Hampshire Regulatory Affairs Specialist / Regulatory Associate / Senior RA Specialist wanted for an immediate start at a leading manufacturer of Medical Devices. Due to rapid growth in the company; they are looking for a Regulatory Affairs Specialist to join their team. The position is based in Hampshire and the Regulatory Affairs Specialist will be directly responsible for handling the international regulatory requirements. This position provides a strong opportunity for a Regulatory Affairs Specialist / Regulatory Associate / Senior RA Specialist to join an expanding team within the Medical Device industry and to develop a career within International Regulatory Affairs. Regulatory Affairs Specialist / Regulatory Associate / Senior RA Specialist: Key Responsibilities: • Support International contacts to gain registration approvals for both new and existing product ranges • Monthly reporting of submissions progress to ensure target submission dates are met. • Support all internal team members with any International regulatory queries or requests they may have. • Ensure timely translations of all product IFUs and labels in accordance to relevant standards and procedures. • Support export/ import requirements. • Submissions to MHRA. • Co-ordinate MHRA application for the import of pharmaceutical products. Responsible for maintaining the effectiveness of the Quality System at the site in accordance with all company requirements and applicable regulations. Regulatory Affairs Specialist / Regulatory Associate / Senior RA Specialist: Experience • Knowledge of regulatory requirements for ISO 13485, MDD (93/42/EEC) and FDA regulations would be highly advantageous. • Good written skills • Ability to work on own initiative and within a team • Ability to work under pressure Apply for this role via the X4 Group today. Or call Lauren Harris on 020 7812 7700 for further details. Keywords: Regulatory / Regulations / ISO 13485 / Regulatory Affairs Specialist / Regulatory Associate / Senior RA Specialist / MDD / FDA / Medical Device Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Mechanical Design Engineer - Electro Mechanical Background Salary/rate £35000 - £50000/annum +Benefits Location Essex Job Number 107787052 Posted 25/05/2012 (16:54) Agency/Employer X4 Group Ltd Description Mechanical Design Engineer Position – Electro-Mechanical Products Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer £35000 - £50000 + Excellent Benefits Essex PERMANENT Mechanical design engineer required to join a leading engineering organisation in Essex. The role will be joining a dedicated engineering team designing and developing high volume precision engineered components to a variety of markets. Commutable Locations: Chelmsford, Braintree, Brantham, Sudbury, Colchester and surrounding locations Reporting to the Engineering Manager, the responsibilities of the job include: - Designing and developing electro-mechanical products from inception through to manufacture - Development of mechanical concepts and designs Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer Qualifications: Essential Requirements for the Mechanical Design Engineer Position: - Strong 3D CAD design background (Solidworks Preferred) - Strong full life cycle background - Electronic Packaging design experience Desirable Requirements for the Mechanical Design Engineer Position: - CFD Analysis - FEA analysis (Thermal Ideal) Interview slots are available from Wednesday 30th May This is a fantastic opportunity for a mechanical design engineer to join an exceptional leading innovative organisation. Apply for this role via X4 Group today Call Arjun Gillard on 02078127700 for further details Keyword search: Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer / CAD / 3D CAD / Solid Works, Pro Engineer, Catia, Autodesk Inventor, AutoCAD Job Type Permanent Contract Length Permanent Start Date ASAP Contact Details

Job Title Immediate 3 - 6 month contract role - Can interview / start next week Salary/rate £18 - £25/hour Location Cambridgeshire, East Anglia Job Number 107792589 Posted 25/05/2012 (16:52) Agency/Employer X4 Group Ltd Description An organisation based in Cambridgeshire require 2 Mechanical Design Engineers for an immediate start. The organisation require a Mechanical Design Engineer with Inventor and a Mechanical Design Engineer with AutoCAD 2D experience to join their highly innovative design team. You must have the ability to work from initial concept through to manufacture as well as representing the organisation in front of important clients. Key skills for the role are - Inventor / AutoCAD 2D Sheet metal fabrication Large fabricated design Documentation Detailing Initial concept through to manufacture design The organisation are looking for a Mechanical Design Engineer to start on Monday 28th May and are keen to interview / have someone start early next week and are looking to pay £18 - £25 per hour depending on experience. Do contact Peter Rabey on 0207 812 7700 for more information on the role. Job Type Contract Contract Length 3 - 6 months Start Date Monday 28th May Contact Details

Job Title Mechanical Design Engineer - Various Mechanical Products Salary/rate £28000 - £38000/annum + Excellent Benefits Location Hampshire, Hampshire Job Number 107791843 Posted 24/05/2012 (17:47) Agency/Employer X4 Group Ltd Description Mechanical Design Engineer – Varied Mechanical Products Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer £28000 - £38000 + Excellent Benefits Hampshire PERMANENT Mechanical design engineer required to join a leading engineering organisation in Hampshire. The role will be joining a dedicated engineering team designing and developing various mechanical products for the defence and medical markets. Commutable Locations: Basingstoke, Salisbury, Winchester, Newbury Reporting to the Engineering Manager, the responsibilities of the job include: - Designing and developing various mechanical products from inception through to manufacture - Customer and client liaising - Hands on testing Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer Qualifications: Essential Requirements for the Mechanical Design Engineer Position: - Strong 3D CAD design background (Pro-Engineer Preferred) - Strong full life cycle background Desirable Requirements for the Mechanical Design Engineer Position: - FEA Analysis (Pro Mechanica) experience - Low Volume Design experience - Plastic injection moulding experience, sheet metal or casting design experience Interview slots are available from Monday 28th May. This is a fantastic opportunity for a mechanical design engineer to join an exceptional leading innovative organisation. Apply for this role via X4 Group today Call Arjun Gillard on 02078127700 for further details Keyword search: Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer / CAD / 3D CAD / Solid Works, Pro Engineer, Catia, Autodesk Inventor, AutoCAD Job Type Permanent Contract Length Permanent Start Date ASAP Contact Details

Job Title Mechanical Design Engineer - High Pressure Technologies Salary/rate £25000 - £34000/annum Location Manchester, Greater Manchester Job Number 107791356 Posted 23/05/2012 (19:32) Agency/Employer X4 Group Ltd Description Mechanical Design Draughtsman–High Pressure Equipment Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer £25000 - £34000 + Excellent Benefits Manchester PERMANENT Mechanical design draughtsman required to join a leading engineering organisation in Manchester. The role will be joining a dedicated engineering team designing and developing high pressure equipment. Commutable Locations: Manchester, Stretford, Sale and surrounding locations Reporting to the Engineering Manager, the responsibilities of the job include: - Designing and developing high pressure equipment from inception through to manufacture - Customer and client liaising Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer Qualifications: Essential Requirements for the Mechanical Design Draughtsman Position: - Strong 3D CAD design background (Solidworks Preferred) - Strong full life cycle background Desirable Requirements for the Mechanical Design Draughtsman Position: You must have one of the following requirements for this position - Hydraulics design experience - Pneumatics design experience - Control system design experience Interview slots are available from Monday 28th May. This is a fantastic opportunity for a mechanical design engineer to join an exceptional leading innovative organisation. Apply for this role via X4 Group today Call Arjun Gillard on 02078127700 for further details Keyword search: Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer / CAD / 3D CAD / Solid Works, Pro Engineer, Catia, Autodesk Inventor, AutoCAD Job Type Permanent Contract Length Permanent Start Date ASAP Contact Details

Job Title Quality Inspector / Quality Control / Graduate Salary/rate £16000 - £18000/annum Location Hampshire, South East Job Number 107791345 Posted 23/05/2012 (18:42) Agency/Employer X4 Group Ltd Description Position: Quality Inspector / Quality Control / Graduate Level Salary: £16,000 - £18,000 Location: Hampshire Quality Inspector / Quality Control / Graduate wanted to join a leading manufacturer of a range of hardware products for the marine industry. Within this role, the Quality Inspector will be responsible for conducting or surface and parts inspections as well as using measuring machinery. This role is ideal for any individual who is looking to begin their career within Quality or Engineering and anyone with a Design / Engineer / Manufacturing Degree or working background would be suitable for this role. Quality Inspector – Key Experiences • To be suitable for this role you will need to have an interest in manufacturing and engineering • Degree level or equivalent in a Design or Engineering background • Relevant experience in the industry is not essential but desirable Apply for this role via the X4 Group Or call Lauren Harris on 020 7812 7700 for further details. Keywords: Quality Inspector / Quality Control / Graduate / Inspection / Design / Engineering / Manufacturing / Degree Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Validation Engineer / Quality Engineer / Process Technician Salary/rate £35000 - £40000/annum Location Norfolk, South East Job Number 120261825 Posted 23/05/2012 (18:33) Agency/Employer X4 Group Ltd Description Position: Validation Engineer / Process Technician / Quality Engineer / Pharmaceutical / Medical Salary: £35,000 - £40,000 Location: Norfolk Validation Engineer / Process Technician / Quality Engineer needed for an immediate start for a Pharmaceutical company based in Norfolk. Validation Engineer / Process Technician / Quality Engineer - Role and Responsibilities: • Design Verification activities in relation to equipment validation and product validation. • To develop Validation Planning with the Quality and Production Managers • To aid the transfer of equipment and products to contract manufacturing facilities • Validation execution including establishing appropriate acceptance criteria and the generation and execution of IQ/OQ/PQs for equipment, processes and products. • Change control and maintenance of the validation history file • Analysis of production and product performance data and the implementation of SPC • Continuous improvement, cost saving strategies and complex problem solving Validation Engineer / Process Technician / Quality Engineer - Essential Requirements: • Good degree in an Engineering or Science related subject plus experience of the role and responsibilities; • Extensive experience in a technical support or validation role within the pharmaceuticals or medical device industry; • Experienced in either the Pharmaceutical, Medical Device or Automotive Industry Apply for this role via the X4 Group today Or call Lauren on 020 7812 7700 for further details. Keywords: Validation Engineer / Process Technician / Quality Engineer / Medical Device / Pharmaceutical / GMP / Good Manufacturing Practice / ISO 13485 / Injection Moulding / Automotive / ISO 9001 Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Medical Device Directive Reviewer / Lead Auditor / Medical Device Salary/rate £40000 - £50000/annum Location Farnham, South East Job Number 107791340 Posted 23/05/2012 (18:25) Agency/Employer X4 Group Ltd Description Position: Medical Device Directive Reviewer / Lead Auditor / Medical Device / ISO 13485 Salary: £40,000 - £50,000 Location: Farnham, Surrey Medical Device Directive Reviewer / Lead Auditor needed to assist in developing project plans and review the outputs of technical file/design dossier assessments and the output of quality management system audits under ISO13485 for both active and non-active medical devices. Medical Device Directive Reviewer / Lead Auditor: Key Responsibilities – • Perform the function of project planning and approving of project plans which includes scoping of the project in terms of technical file sampling rates and quality management system auditing requirements, ensuring appropriate technically competent assessment personnel are identified. • Provide an independent and impartial review of assessment outputs of active and non-active medical devices, including technical file/design dossier assessment outputs and quality management system assessment outputs. • Ensure that the project plan was executed as originally approved or that changes are duly justified and a rationale provided. • Interfaces with the MHRA on an as needed basis. • Participate in the development of requirements and assessment methods. Integrates continuous improvement concepts into all aspects of the job. • Some UK/Overseas travel may be required. Medical Device Directive Reviewer / Lead Auditor: Experience – • A relevant Degree in Electronic Engineering or Degree equivalent such as HTEC/HNC/HND/City & Guilds • Extensive experience with MDD 93/42/EEC with awareness of new MDD 2007/47/EC including MEDDEVS; • Experience with ISO 10993 relating to Biocompatibility; • Experience with ISO 13485 relating to Quality Management Systems • Experienced with IEC 60601 assessments of conformity; • Experienced with Device Software Assessment IEC 62304 standards; • Experience of Risk Management File and processes under ISO 14971 for Medical Devices • Additional experience in Non Active Medical Devices, Analytical Chemistry, Toxicology, Bio-analysis, Microbiology or Pharmacological testing would be useful. Apply for this role via the X4 Group Or call Lauren Harris on 020 7812 7700 for further details Keywords: Medical Device / ISO 13485 / Auditor / Audit / MHRA / IVD / Reviewer / MDD / IEC 60601 / ISO 10993 / Risk Management Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Software Design Engineer / LabVIEW Engineer / Software Designer Salary/rate £33 - £44/hour Location Cambridgeshire Job Number 107790605 Posted 22/05/2012 (19:01) Agency/Employer X4 Group Ltd Description Software Design Engineer / LabVIEW Engineer / Software Designer wanted for up and coming company based in Cambridgeshire. Commutable locations: Cambridgeshire, Bedfordshire, Essex, Hertfordshire, Norfolk, Suffolk. Essential skills needed: - 3 years + experience of designing and implementation of LabVIEW software for test system development - Working knowledge of test equipment e.g. network analysers, power supplies etc. - Worked within a small team - Use of source control tools Desirable skills: - Good working knowledge of RF test systems - Working knowledge of Matlab - Working knoeldge of either WCDMA and/or LTE air interfaces Interviews will take place from 24th May through to 1st June. This is a fantastic opportunity for a Software Design Engineer / LabVIEW Engineer / Software Designer. Send your CV to Careers at the X4 Group today or call 0207 812 7700 for more details. Job Type Contract Contract Length 3 - 6 months Start Date Contact Details

Job Title Quality Engineer / Quality Assurance / QA Engineer / Pharmaceutical Salary/rate £28000 - £30000/annum Location Sur, South East Job Number 120261650 Posted 22/05/2012 (18:27) Agency/Employer X4 Group Ltd Description Position: Quality Engineer / Quality Assurance / QA Engineer / Pharmaceutical Salary: £28,000 - £30,000 Location: Guildford, Surrey Quality Engineer / Quality Assurance / QA Engineer needed to support activities for a new range of products being developed and commercialised at within a Pharmaceutical Company based in Surrey. Quality Engineer / Quality Assurance / QA Engineer: Key Responsibilities - 1. Assist in the maintenance, management and organisation of Quality Assurance. Ensure that departmental objectives are implemented in line with the overall Quality/Corporate goals. 2. Assist in ensuring departmental understanding and compliance with the requirements of cGMP. Providing cGMP training and support to departments. Assist in applications for regulatory approval. 3. Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements. 4. Ensure effective coordination and QA leadership for the CAPA Team, including initiating investigations, root cause analysis, risk assessments and implementation of change controls and CAPA as appropriate; focus on Continuous Improvement opportunities. 5. Review and assist in process capability studies and statistical techniques as necessary, to support continuous improvement. Initiate updates/tracking on status of Quality Events and CAPAs as appropriate. 6. In conjunction with Quality team, evaluate Quality Events / Non Conformances. Identify corrective and preventive action; determine assignable root cause, complete failure investigations and follow up to corrective and preventive actions, ensuring adequate and timely closure. 7. Conduct review of Change Control Requests, ensuring compliance with cGMP and quality standard requirements. Follow up on recommended actions. 8. Oversight as required for Supplier Management for the range of products, partnering with the wider quality team and other business stakeholders. 9. Implement and report Key Performance Indicators for the quality system processes. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training as appropriate. 10. Prepare and present quality reports, data and Key Performance Indicators to management for review at quality review / council meetings. 11. Review and coordinate packaging and labelling change requests, update regulatory authorities as appropriate. 12. Participate in the development and maintenance of the Company's Quality System to meet the requirements of the relevant regulatory authorities, Notified Bodies (if applicable) and ISO standards (as applicable) and all other applicable quality and regulatory standards. Quality Engineer / Quality Assurance / QA Engineer: Education and Experience 1. Degree in science discipline (chemistry, biology or medical technology preferred). 2. Desired, recognised Quality qualification, e.g. CQI Diploma in Quality 3. Significant experience in a drug manufacturing, medical device or biologics industry in Quality Assurance, Quality Control or Quality Engineering position. 4. Demonstrated knowledge of document control systems. 5. Experience with internal and external audit processes 6. Demonstrated knowledge of cGMPs, MHRA, FDA regulations and SOPs. Quality Engineer / Quality Assurance / QA Engineer: Skills and Attributes 1. Demonstrated advanced computer skills – Microsoft Office preferred. 2. Excellent verbal, written and interpersonal skills, including the ability to conduct verbal presentations appropriate to the level of the audience. 3. Demonstrated success working in a team environment. Apply for this role via the X4 Group today. Or call Lauren Harris on 0207 812 7700 for further details. Keyword: Pharmaceutical / Pharmacy / Pharma / GMP / Good Manufacturing Practice / CAPA / Quality Assurance / Quality Engineer / Quality Assurance Engineer / QA Engineer / cGMP / KPIs / Non-Conformances / NCRs Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Mechanical Design Engineer - Electro Mechanical Products Salary/rate £23000 - £30000/annum +Healthcare, Pension, Location Derbyshire Job Number 107790121 Posted 21/05/2012 (18:51) Agency/Employer X4 Group Ltd Description Mechanical Design Draughtsman– Electro-mechanical Products Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer £23000 - £30000 + Excellent Benefits Derbyshire PERMANENT Mechanical design draughtsman required to join a leading engineering organisation in Derbyshire. The role will be joining a dedicated engineering team designing and developing electro-mechanical products. Commutable Locations: Sheffield, High Bradfield, Hayfield, Bakewell and surrounding locations Reporting to the Engineering Manager, the responsibilities of the job include: - Designing and developing electro-mechanical products from inception through to manufacture - Customer and client liaising Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer Qualifications: Essential Requirements for the Mechanical Design Draughtsman Position: - Strong 3D CAD design background (Solidworks or Solid Edge Preferred) - Strong full life cycle background - Mechanical Component Design Desirable Requirements for the Mechanical Design Draughtsman Position: - Fabrication design experience - Machined components design experience - Sheet metal design experience Interview slots are available from Monday 28th May. This is a fantastic opportunity for a mechanical design engineer to join an exceptional leading innovative organisation. Apply for this role via X4 Group today Call Arjun Gillard on 02078127700 for further details Keyword search: Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer / CAD / 3D CAD / Solid Works, Pro Engineer, Catia, Autodesk Inventor, AutoCAD Job Type Permanent Contract Length Permanent Start Date ASAP Contact Details

Job Title Risk Management / Risk Assessment / ISO 14971 / Safety Engineer Salary/rate £32000 - £38000/annum Location Redhill, West Sussex Job Number 107790119 Posted 21/05/2012 (18:41) Agency/Employer X4 Group Ltd Description Position: Risk Management / Risk Assessment / ISO 14971 / Safety Engineer Salary: £32,000 - £38,000 Location: West Sussex Risk Manager / Risk Assessor / ISO 14971 / Safety Engineer needed to ensure that the safety process is applied effectively to the project. The Risk Manager / Risk Assessor / ISO 14971 / Safety Engineer will provide a co-ordinating and facilitating role to ensure safety tasks on the project are completed and that safety is central to all the teams’ activities. Risk Management / Risk Assessment / ISO 14971 / Safety Engineer : Key Responsibilities: • Planning safety activities appropriate to the size of the project and commensurate with the risk from the intended use and characteristics of the product. • Ensure that the planned activities are applied effectively throughout the project. • Ensure suitable techniques are applied to analyse design and design changes to identify hazards, causes of hazards and estimate their risk and record the evidence of this analysis • Ensure appropriate risk control measures are applied to reduce the risk from hazards to an acceptable level. • Review the safety activities for completeness and effectiveness and prepare a safety case on behalf of the project team that argues activities for the project have sufficient progress and risk is acceptable to release the product. Where the risk is not accepted by the project team, provide the Project Steering Group with the information necessary to make an informed decision regarding release. Post Production Assessment: • Perform risk assessment on problems on released products reported through the Customer Feedback Reporting Process Process improvement: • Use expertise to support the Senior Safety Engineer in process improvement activities to respond to changes in standards, and improve the efficiency of the safety assessment process Risk Management / Risk Assessment / ISO 14971 / Safety Engineer: Qualifications: • Risk Management policy and principals; Risk Management processes; Usability principles and procedures; Safety standards, preferably including IEC 61508; Sector specific knowledge is desirable, including ISO 14971, IEC 60601. • A degree in science or engineering would be highly desirable • Applying Hazard Identification and Risk assessment methods as part of a development process; Creating risk assessments on systems (preferably both software and hardware); Report writing; Document reviews; Design reviews. • Good communication, in particular through documentation and report writing; Analytical and logical; Commitment to complete assignments and ability to work as part of a team; Able to use initiative, remain objective, escalate and seek advice as appropriate. Apply for this role via the X4 Group Or call Lauren Harris on 020 7812 7700 for further details Keywords: Risk Manager / Risk Management / Safety Advisor / Safety Engineer / Risk Assessor / Risk Assessment / ISO 14971 / Medical Devices / ISO 13485 / IEC 60601 / IEC 61508 / Project Management / SOPs / Health and Safety / Product Safety Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Lead Auditor / Qualified Auditor / External Auditor / Notified Body Salary/rate £40000 - £45000/annum Location Surrey, South East Job Number 120261459 Posted 21/05/2012 (18:25) Agency/Employer X4 Group Ltd Description Position: Lead Auditor / Qualified Auditor / External Auditor / Notified Body / ISO 13485 / IVD Salary: £40,000 - £45,000 Location: Surrey Lead Auditor / Qualified Auditor / External Auditor wanted to join a Notified body based in Surrey. The Lead Auditor / Qualified Auditor / External Auditor will be responsible for outlining the scope of assessments, select auditors, plan, and manage assessments. The Lead Auditor will be responsible for leading the audit teams in assessing the conformance of a management system to appropriate standards and requirements. Extensive overnight travel will be required. Lead Auditor / Qualified Auditor / External Auditor / Notified Body / ISO 13485: Key Responsibilities: • Verify that scope of assessment meets contractual agreements, presenting scope of assessments and plans to clients. Manage the assessment. • Verify the existence of and implementation of management system elements. Prepare and present assessment reports • Determine customer’s degree of readiness for assessment to appropriate standards. Assist customer in understanding the requirements of the standard or standards. • Direct the conduct of the assessment project and the activities of assessment team members. • Assess the conformance of a quality system to appropriate standards by analysing client manuals, contracts, engineering records, and other appropriate documents. Interview client staff to obtain additional information. • Conduct Technical File assessments, if needed • Document assessment results, including areas of non-conformance and prepare and present assessment reports. • Documentation reviews, including review assessment results. • Assist in development of training materials in areas of expertise. • Significant UK/Overseas travel will be required. Lead Auditor / Qualified Auditor / External Auditor / Notified Body / ISO 13485: Key Experience: • Substantial auditing experience, ideally with another registration body; • Experience with ISO 13485 relating to Quality Management Systems (experience with ISO 14971 an advantage); • Technical knowledge and experience in MDD audits is essential; additional IVD background/experience desirable. • Experience with CMDCAS (Canadian Program); • IRCA member • Fluent English language skills essential and preferably a second language. • Excellent verbal and written communication skills. • Strong innovative and analytical skills Apply for this role via the X4 Group today. Or call Lauren Harris on 0207 812 7700 for further details. Keywords: Lead Auditor / Qualified Auditor / External Auditor / Notified Body / ISO 13485 / IVD / Medical Device / Audit / Internal Audit / 14971 / CMDCAS / Canadian / Regulations / Class 1 / Class 2 / Class 3 / Implantable / Technical File / NCR / Non-conformances / Supplier Auditor / Supplier Management Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Quality Manager / Senior Quality Engineer / Medical Device / ISO13485 Salary/rate £35000 - £40000/annum Location Kent , South East Job Number 120261273 Posted 18/05/2012 (16:56) Agency/Employer X4 Group Ltd Description Role: Quality Manager / Senior Quality Engineer / Medical Device / ISO13485 Salary: £35,000 - £40,000 Location: Gillingham Quality Manager / Senior Quality Engineer / Medical Device / ISO13485 specialist need to join a leading Medical Device manufacturer in Gillingham. The Quality Manager / Senior Quality Engineer will be needed to ensure that all Quality Management Systems adhere to ISO13485 and all other relevant regulatory standards. The Quality Manager / Senior Quality Engineer will be directly responsible for ensuring that the Quality team conduct daily routines to ISO13485 standards and that all activities conducted accurately and effectively. To be suitable for this role, you will need to be experienced with QMS, within the Medical Device industry, specifically in regards to manufacturing processes, equipment facilities and utilities. Quality Manager / Senior Quality Engineer / Medical Device / ISO13485: Key Responsibilities: • To ensure the effective development and execution of Quality Management Strategies • To investigate deviations and coordinate the CAPA process • To manage the Quality Review Process • To ensure that your team support complaint investigations • Prepare for external audits from regulatory bodies and to ensure inspection readiness Quality Manager / Senior Quality Engineer / Medical Device / ISO13485: Qualifications / Experience • Extensive knowledge of QMS within the Medical Device industry is essential • ISO 13485 • In depth knowledge of the Validation is also a key requirement • CAPA • Managing internal audits and preparing for external audits • Degree level or equivalent in any scientific discipline • Must be familiar with regulatory requirements i.e. MHRA, ISO and FDA This role requires an individual to have the initiative to undertake personal and departmental goals to meet business objectives and to ensure QMS are maintained to all regulatory standards. Apply for this role via the X4 Group today. Or call Lauren Harris on 020 7812 7700 for further details. Keywords: Quality Manager / Senior Quality Engineer / Medical Device / ISO13485 / GMP / FDA / MHRA / Lead Auditor / CAPA / Validation / Validation Engineer / Degree / Management / Manager / Audit / Auditing / QMS / Complaint Handling Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Quality Team Leader / Senior Quality Engineer / ISO 13485 Salary/rate £35000 - £40000/annum Location Luton, South East Job Number 120260960 Posted 16/05/2012 (18:35) Agency/Employer X4 Group Ltd Description Position: Quality Team Leader / Senior Quality Engineer / ISO 13485 / Medical Device / Senior Quality Assurance Specialist Salary: £35,000 - £40,000 Location: Luton Quality Team Leader / Senior Quality Engineer / ISO 13485 / Medical Device / Senior Quality Assurance Specialist wanted for an immediate start to lead and co-ordinate the actions and continuous improvement activities of the team in meeting customer quality requirements which will include the maintenance of Quality Assurance systems. The Quality Team Leader / Senior Quality Engineer / ISO 13485 / Medical Device / Senior Quality Assurance Specialist will be required to conduct internal and external audits to ISO9001/ISO13485 standards in order to maintain accreditation. Quality Team Leader / Senior Quality Engineer / ISO 13485 / Medical Device / Senior Quality Assurance Specialist: Key Responsibilities - • Lead all Quality control activities • Champion a dynamic and proactive quality culture • Design and facilitate Internal Audit programmes to over ISO9001 / ISO13485 / GMP • Implement and maintain ISO9001 / ISO13485 / GMP / FDA / Medical device standards in R&D, QA and Process areas • Document, review and approve Customer Specifications • Setting and maintaining standards of performance, reporting Quality KPI’S • Carrying out process capability studies • Ensuring key raw material specifications are aligned to customer specifications • Ensuring incoming goods are conforming to specification • To integrate with both customers and suppliers with regards to quality problem resolution and improvement initiatives • Facilitate reporting and actions on internal and external customer complaints • Ensure all bio-burden and pest controls are compliant to standard • Facilitate the completion of customer questionnaires • Ensuring effective communication within the team • Ensuring a safe and clean working environment • Supporting the development of new product Quality Team Leader / Senior Quality Engineer / ISO 13485 / Medical Device / Senior Quality Assurance Specialist: Education and Experience • • Preferably degree qualified or equivalent in Manufacturing and/or chemical engineering with certification as an Auditor in the area of ISO9001 / 13485 standards. • PC literate with a high standard of communication skill, both verbal and written. • The ability to work using own initiative when required, but also showing aptitude as a team player. • Can implement continuous improvement programmes • Medical device knowledge of CE, FDA and GMP experience • Previous Quality Assurance Supervision / Manager experience in a Medical Device manufacturing would be a distinct advantage. Apply for this role via the X4 Group today Or call Lauren Harris on 020 7812 7700 for further detail Keywords: Quality Team Leader / Senior Quality Engineer / ISO 13485 / Medical Device / Senior Quality Assurance Specialist / Continuous Improvement / ISO 9001 / Audit / Lead Audit / Luton / GMP / FDA / Inspection / Manager / Management Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Immediate 3 - 6 month contract role - Can interview this week Salary/rate £18 - £22/hour Location Kent Job Number 107788155 Posted 16/05/2012 (18:33) Agency/Employer X4 Group Ltd Description An organisation based in Kent are looking for 1 maybe 2 Mechanical Design Engineers to join their highly innovative design team on an initial 3 - 6 month contract. You must have experience with AutoCAD and have the ability to work closely with the manufacturing department. The organisation have been within their market for over 25 years and have a strong reputation so they need to bring in an engineer who will have the ability to think on their feet and adapt to the ever changing drawing environments. Key skills required for the role are - AutoCAD Large fabrication drawings Detailing Documentation Design for manufacture The organisation are looking for a Mechanical Design Engineer to start as soon as possible though they can wait up to 2 weeks for the right candidate and are looking to pay £18 - £22 per hour depending on experience. Do contact Peter Rabey on 0207 812 7700 for more information on the role. Job Type Contract Contract Length 3 - 6 months Start Date ASAP Contact Details

Job Title Validation Engineer / Quality Engineer / D.O.E / Continuous Improvemen Salary/rate £38000 - £40000/annum Location Morden, West Sussex Job Number 120260796 Posted 16/05/2012 (08:22) Agency/Employer X4 Group Ltd Description Position: Validation Engineer / Quality Engineer / D.O.E / Continuous Improvement / ISO 13485 / Medical Device Salary: £38,000 - £40,000 Location: West Sussex Validation Engineer / Quality Engineer / Continuous Improvement Specialist needed for an immediate fill for a Medical Device company based in West Sussex. The Validation Engineer will represent Quality Engineering at various meetings (Validation, Customer, Quality Reviews, Sampling) and provide validation and metrology input as required. To be suitable for this role you will need to have extensive experience of design experience specifically within Taguchi and Factorial. Validation Engineer / Quality Engineer / D.O.E / Continuous Improvement - Key Responsibilities • Work with Project Managers, Quality Engineering and Tooling Engineers during tool validation projects. • Produce Tooling Validation Protocols for FAT, SAT. IQ, OQ & PQ using templates within the QMS. • Produce DoE protocols for use when validating injection mould tools. These would be based on Taguchi and Factorial experimentation, • Supervise and/or organise execution of validation protocols, ensuring data is captured and deviations are logged. • Completion of validation reports based on analysis of metrology data following execution of validation protocols or tooling modifications. • Produce and execute Gauge R&R studies. Validation Engineer / Quality Engineer / D.O.E / Continuous Improvement - Key Experience • General understanding of statistics (experience with Minitab would be desirable) • Validation Report writing and executing • Understanding of polymer injection moulding would be desirable. • Proven suitable experience within a Validation Engineering role could be accepted as an equivalent • Experience of using non-contact measuring machines and hand held measuring devices • Experience of writing and executing validation protocols, preferably for moulding tools. • Knowledge of ISO13485:2003 and ISO9001:2000 is preferred There is an immediate need for this position and interviews are taking place from this week therefore if you are interested in the role apply via the X4 Group. Or call Lauren Harris on 020 7812 7700. Keywords: Validation / Validation Engineer / Quality / Quality Engineer / Quality Assurance / ISO 13485 / Medical Device / Continuous Improvement / Six Sigma / Kaizen / 5Y / 8D / Design of Experiments Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Mechanical Design Engineer - Automotive Industry Salary/rate £30000 - £38000/annum +Benefits Location Mid Glamorgan, Mid Glamorgan Job Number 107787551 Posted 15/05/2012 (18:03) Agency/Employer X4 Group Ltd Description Mechanical Design Engineer Position – Automotive Products Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer £30000 - £38000 + Excellent Benefits Wales PERMANENT Mechanical design engineer required to join a leading engineering organisation in Wales. The role will be joining a dedicated engineering team designing and developing automotive products. Commutable Locations: Swansea, Bridgend, Port Talbot, Newport, Cardiff and surrounding locations Reporting to the Engineering Manager, the responsibilities of the job include: - Designing and developing automotive products from inception through to manufacture - Development of mechanical concepts and designs - Creating and maintaining design FMEAs Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer Qualifications: Essential Requirements for the Mechanical Design Engineer Position: - Strong 3D CAD design background (Catia Preferred) - Strong full life cycle background - Injection moulding or sheet metal background Desirable Requirements for the Mechanical Design Engineer Position: - Automotive design background - Component design background Interview slots are available from Friday 18th May This is a fantastic opportunity for a mechanical design engineer to join an exceptional leading innovative organisation. Apply for this role via X4 Group today Call Arjun Gillard on 02078127700 for further details Keyword search: Mechanical Engineer/ Mechanical Design Engineer / Project Engineer / Mechanical Development Engineer / CAD / 3D CAD / Solid Works, Pro Engineer, Catia, Autodesk Inventor, AutoCAD Job Type Permanent Contract Length N/A Start Date Contact Details

Job Title Audio DSP Engineer - DSP Engineer - Audio Salary/rate £26 - £35/hour Location Bedfordshire, Bedfordshire Job Number 107787036 Posted 14/05/2012 (18:02) Agency/Employer X4 Group Ltd Description Audio DSP Engineer / DSP Engineer / Audio Engineer needed for immediate contract position based in Bedfordshire. This is for an Audio DSP Engineer, requiring key skills in: - Audio experience - DSP experience - Experience of C/C++ - Experience of Matlab would be an advantage Your main roles will include: - Collecting analogue data and convert to frequency response (depending on project and processor) - Code writing around these concepts - Working within a small company Interviews are being held between 16th-25th May with an immediate start preferred. This is a fantastic opportunity to work with an up-and-coming company in the audio field. Send your CV to X4 Group tofay. Job Type Contract Contract Length 3 - 6 months Start Date 28th May Contact Details

Job Title Safety Engineer / ISO 14000 / ISO 14971 / Risk Management / Medical De Salary/rate £32000 - £38000/annum Location West Sussex, South East Job Number 107786230 Posted 11/05/2012 (17:01) Agency/Employer X4 Group Ltd Description Position: Safety Engineer / ISO 14000 / ISO 14971 / Risk Management / Medical Device Salary: £32,000 - £38,000 Location: West Sussex Safety Engineer / ISO 14000 / ISO 14971 / Risk Management specialist needed to ensure that the safety process is applied effectively to the project. The Project Safety Engineer / ISO 14000 / ISO 14971 / Risk Management Engineer provides a co-ordinating and facilitating role to ensure safety tasks on the project are completed and that safety is central to all the teams’ activities. Safety Engineer / ISO 14000 / ISO 14971 / Risk Management specialist: Key Responsibilities: • Planning safety activities appropriate to the size of the project and commensurate with the risk from the intended use and characteristics of the product. • Ensure that the planned activities are applied effectively throughout the project. • Ensure suitable techniques are applied to analyse design and design changes to identify hazards, causes of hazards and estimate their risk and record the evidence of this analysis • Ensure appropriate risk control measures are applied to reduce the risk from hazards to an acceptable level. • Review the safety activities for completeness and effectiveness and prepare a safety case on behalf of the project team that argues activities for the project have sufficient progress and risk is acceptable to release the product. Where the risk is not accepted by the project team, provide the Project Steering Group with the information necessary to make an informed decision regarding release. Post Production Assessment: • Perform risk assessment on problems on released products reported through the Customer Feedback Reporting Process Process improvement: • Use expertise to support the Senior Safety Engineer in process improvement activities to respond to changes in standards, and improve the efficiency of the safety assessment process Safety Engineer / ISO 14000 / ISO 14971 / Risk Management Specialist - Qualifications: • Risk Management policy and principals; Risk Management processes; Usability principles and procedures; Safety standards, preferably including IEC 61508; Sector specific knowledge is desirable, including ISO 14971, IEC 60601. • A degree in science or engineering would be highly desirable • Applying Hazard Identification and Risk assessment methods as part of a development process; Creating risk assessments on systems (preferably both software and hardware); Report writing; Document reviews; Design reviews. • Good communication, in particular through documentation and report writing; Analytical and logical; Commitment to complete assignments and ability to work as part of a team; Able to use initiative, remain objective, escalate and seek advice as appropriate. Apply for this role via the X4 Group Or call Lauren Harris on 020 7812 7700 for further details Keywords: Safety Engineer / ISO 14000 / ISO 14971 / Risk Management / Risk Assessment / Medical Devices / ISO 13485 / IEC 60601 / IEC 61508 / Project Management / SOPs / Health and Safety / Product Safety Job Type Permanent Contract Length N/A Start Date Contact Details

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