HEAD OF QUALITY ASSURANCE – MEDICAL DEVICES – MAIDENHEAD, UK

CONTRACT – 6 MONTHS

About our Client:

Our client is known to create multiple breakthrough products, in diagnostic, medical devices, nutrition and branded generic pharmaceuticals that help you, your family and your community lead healthier lives, full of unlimited possibilities.

 

Role and responsibilities:

 

  • Lead the newly restructured QA function within the business, managing everyday running of the QMS within a world class development facility
  • QMS Management: ISO13485:2016 development, maintenance and improvement
  • Lead SOP development, ensuring compliance
  • Management of internal auditing, including the facilitation of 3rd party audits
  • Training of staff on quality procedures and implementation of a quality culture within the business
  • Non-conformance investigation and CAPA implementation
  • Management of the QA department; responsibility for the growth and development of the team

 

Essential Experience and Skills: 

 

  • Engineering or Scientific Degree or equivalent
  • Significant working knowledge in medical device QA, especially within ISO13485 and MDD guidelines
  • Experience in medical device consultancy or multiple devices is advantageous
  • Strong FDA QSR knowledge
  • Leadership experience – managing teams and multiple projects

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