Quality System Control Specialist

Quality System Control Specialist

Biotechnology Life Sciences


Salary £26,000 - £35,000

Contract Permanent

Reference HMQSDC

Date Posted


Apply now

7 weeks left to apply

We are currently looking for a Quality System Specialist (Design Control) to join a leading specialised medical diagnostic company in Birmingham. The role will involve ensuring NPD and Change Control systems are followed according to ISO9001 and ISO13485.

Key responsibilities and duties:

  • Ensure all verification, validation and other requirements before internal release approval of new products
  • Review, approve and manage the progression to completion of Change Orders
  • Provide QA support across the business
  • Ensure compliance to External and Internal Quality System requirements
  • Support internal and external audits as required
  • Organise and schedule meetings for Change Control and NPD
  • Awareness of risk management systems (DFMEA, PFMEA)

Ideal skills and qualifications:

  • Degree in Biological Sciences or similar; or equivalent industrial experience
  • Proven experience within a QA or RA environment in an IVD/medical device company
  • Experience of Non-Conforming Product and Corrective Action systems
  • Working knowledge of FDA Part 820, 806, 803 and ISO13485
  • Excellent attention to detail and ability to follow processes
  • Strong interpersonal and communication skills

If you are interested or have any questions about this role, feel free to contact Harriet at CY Partners.

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Quality System Control Specialist

Biotechnology Life Sciences

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7 weeks left to apply

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