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Quality Engineer

Competitive Salary
Chepstow, Monmouthshire
Monday – Friday,


The THOMAS Recruitment Group are recruiting on behalf of a global medical company based in South Wales. Our client is seeking a Quality Engineer to join their team on a permanent basis.

Duties will involve

  • Offering pragmatic guidance on compliant routes to market that ensure robust documentary evidence and timely achievement of project goals.
  • Provide regulatory and quality education and training where appropriate.
  • Be the risk management authority on the project team to ensure that there is a favourable risk/benefit ratio and suggest plans and strategies for reduction of risk. Review and approve the risk management output.
  • Develop the master validation plan 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.
  • 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.
  • 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.
  • Review and approve all project related documentation that will be used to demonstrate compliance to regulatory requirements.
  • Develop a professional working arrangement with the teams to promote quality values throughout.
  • Responsible for verifying that project teams are operating in compliance with Medical Standard Operating Procedures for new product development.
  • Identifying and reporting deficiencies to the teams and management in accordance with the non-conformance process.

Skills and Experience

  • Must have previous experience in a Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment.
  • Must have sufficient knowledge of the following regulations to act as the subject matter expert within the development team: – ISO 13485 and/or FDA 21 CFR part 820, BS EN 14971.
  • Working knowledge of ISO 10993, IEC 60601 ISO 11137 desirable.
  • An understanding of process validation, process control and statistics cleanroom manufacturer, electronics manufacturing techniques desirable.

Additional Information

  • Able to work to deadlines
  • Training in ISO 13485 and/or QSR 21 part 820
  • Training in risk management to ISO 14971
  • Must show great attention to detail
  • Must be reliable
  • Good understanding of engineering principles and terminology
  • Must be proactive
  • Excellent people and communication skills
  • Must have a sense of urgency in making things happen
  • Good working knowledge of Office 365

The THOMAS Recruitment Group are an Employment Business. We supply temporary, contract and permanent staff to various companies throughout the UK to various sectors.

Located in South Wales, Midlands & the South West, we recruit for temporary and permanent job roles across the following core areas:


If you are interested in this position, then please click ‘APPLY NOW’ below

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    Simona Johnson
    Simona Johnson
    10:35 16 Mar 21
    I have a very good experience with Thomas Recruitment agency. I would like to thank Jacky for help. She found me a very good job. Jacky is... professional and always ready to cooperate. I highly recommend this agency and I appreciate everything they did for me. 😊👍read more
    Paul Tomlin
    Paul Tomlin
    15:33 17 Feb 21
    One of the best recruitment agencies I have had the pleasure to deal with, always keep you informed of current vacancies
    Mark Williams
    Mark Williams
    12:53 17 Feb 21
    I would like to say that Jackie and the staff at pontypridd are excellent have had problems and a number of health issues since starting knight... securities in wages have always been correct and I have been enjoying where I been working. unfortunately my health problems have made me unavailable for work and the staff at both knights and Thomas recruitment have been fantastic. Thank you more
    John Hopkins
    John Hopkins
    10:57 17 Feb 21
    I have worked for Thomas Recruitment for a while. They have consistently kept me in work and I have never had any cause to complain. Friendly and... more
    Sandra WILKINS
    Sandra WILKINS
    12:31 15 Feb 21
    I have had nothing but help from Jacky at Pontypridd branch very helpful and friendly
    nigel ostler
    nigel ostler
    21:15 09 Feb 21
    I have had a very positive experience overall with Thomas Recruitment. I am an experienced class 2 hgv driver and have had plenty of work over the... past 18 months through the agency. They pay ontime, keep you informed and are very willing to help with any issues that may occur. I can't comment on other industries they recruit for but its a big thumbs up for all at Thomas Driving from more
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