Jonathan Lee Recruitment Looking for Qaulity Engineer at Chepstow , Gwent Full Time

Jontahn Lee Recruitment are working with a Global Medical Device compnay based in Chepstow, the role entail:

In this role you will provide Quality Engineering support in the design and development team, particularly for carrying out quality engineering processes and the generation and/or review and approval of associated records in compliance with the requirements of ISO 13485:2016 and US FDA quality system regulations. The role is essential to ensuring products are designed, developed and manufactured to a high standard and support compliance to regulatory requirements. The role requires close and proactive working with design/development engineers and technicians, production, purchasing and materials control personnel and other  personnel as necessary.

Key tasks for the position holder:

• Work with the product development teams to create a robust and compliant, Product Quality Plan. Verify that project teams are operating in compliance with plan and Standard Operating Procedures for new product development.
• Offer pragmatic guidance to the project teams on creating robust documentary evidence to support compliance and timely achievement of project goals.
• Develop a professional working arrangement with the teams to promote quality values throughout.
• Provide quality education and training where appropriate.
• Identify and report deficiencies to the teams and management in accordance with the non-conformance process.
• Support the risk management process with the project teams to ensure that there is a favourable risk/benefit ratio and suggest plans and strategies for reduction of risk. Review the risk management output. Monitor changes to the project to ensure that the risk file remains compliant.
• Where required, review and approve project related documentation used to demonstrate compliance to regulatory requirements.
• Develop the master validation plan with the project team for the introduction of manufacturing equipment and processes into production. Liaise with Manufacturing Engineers and Operations to ensure that validation activities are planned, of sufficient depth and implemented effectively.
• Review and approve validation protocols including IQ, OQ and PQ, providing support for any statistical techniques and analysis required.
• Working closely with the design team, identify appropriate critical to quality features and generate first article inspection and goods receiving inspection plans, ensuring that appropriate measurement techniques are available.
• Work with the Supplier Quality Engineer to ensure that the design supply base is sufficiently robust to ensure delivered product is compliant.
• Review and approve verification and validation documentation to ensure that design outputs meet input requirements and that user needs are met. Ensure that verification test methods have been adequately validated before use. Support the team to identify suitable test methods and validation approaches. Ensure that reports generated meet the protocol requirements and Good Document Practice.

Qualifications, experience and competencies required:

• Degree qualified in an engineering, medical or other relevant subject.
• Previous experience in a Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment is desirable, but fron Aerospace / Defence / Automitve is OK.
• There is an emphasis on candidates having experience of supporting new product development teams in a quality role i.e. supporting them through the regulatory pathway from the definition of a project to release to market primarily in the US or Europe. This will involve review and generation of technical file documentation and ensuring that teams are operating to the quality system and regulatory requirements.
• A understanding of the following regulations is desirable :- ISO 13485 and/or FDA 21 CFR part 820, BS EN 14971.
• Working knowledge of ISO 10993, IEC 60601 ISO 11135 desirable.
• An understanding of process validation, process control and statistics cleanroom manufacturer, electronics manufacturing techniques desirable.
• Proactive
• Able to work to deadlines
• Attention to detail
• Excellent people and communication skills
• Sense of urgency – make things happen/get results
• Reliable
• Excellent problem-solving skills
• Good understanding of engineering principles and terminology
• Good working knowledge of Office 365

Suitably qualified and experienced Quality Engineers should apply by contacting Paul Coates at Jonathan Lee Recruitment +44 (0) 1926963292 or by emailing their CV to

Your CV will be forwarded to Jonathan Lee Recruitment, a leading engineering and manufacturing recruitment consultancy established in 1978. The services advertised by Jonathan Lee Recruitment are those of an Employment Agency.