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  • Location: Oxford
  • Salary: Very competitive salary + benefits
  • Job Type:Permanent

Posted 29 days ago

  • Sector: Quality, MedTech
  • Contact: Steve Twinley
  • Contact Email:
  • Contact Phone: 01403 216216
  • Start Date: 2021-09-23
  • Job Ref: V-47037
Are you a versatile and conscientious Quality Assurance professional, with a practical background in the application of ISO13485 quality principles and FDA Quality System requirements within the IVD or Medical Devices industry? A pioneering biotechnology organisation on the outskirts of Oxford is looking for a QA Manager, to bring significant expertise and help with the exciting expansion of the company from the perspective of developing robust, scalable quality systems.
This is a permanent position, on site in Oxford, offering an excellent salary and benefits package to discuss on application.
We are looking for a self-motivated individual to lead the implementation and management of a QMS, working in collaboration with internal and external parties. You must be able to demonstrate a rounded knowledge of reagent development and software development in the context of IVD Point of Care (near-patient) Testing whilst meeting ISO 13485 and FDA design control requirements.
Your role will include:

  • Leading the implementation and management of QMS processes
  • Supporting the design and development of new products in line with ISO 13485 and FDA QSR requirements.
  • Working as part of project teams to ensure QMS and applicable regulatory compliance.
  • Supporting CE Marking via IVDR (2017/746).
  • Supporting US Market Clearance via 510(k).
  • Supporting the development of assessment approaches and techniques for the management of key Suppliers and Contract Design and Contract Manufacturing Partners.
  • Providing compliance oversight of process validation activities at supply partners.
  • Executing and reporting on necessary assessments of internal process and external processes, including supplier audits and contract design/manufacturer evaluations.
  • Supporting the day-to-day administrative requirements of the quality management system as required, including document control and record keeping.
  • Providing QA team resource for the day-to-day administrative requirements of the quality management system, including but not limited to CAPA, document control and record keeping.
  • Assisting in the design of training programmes for QMS procedure implementation.
  • Training employees companywide in QMS procedures owned by QA.
  • Auditing the implementation of QMS procedures for compliance and effectiveness.
  • Revising processes in line with audit findings.
Skills and Experience Required:

  • Strong Quality Management background, gained within an ISO13485 regulated environment in Medical Devices and / or In Vitro Diagnostics (IVDs)
  • Life science degree or higher
  • High emotional intelligence, with a conscientious approach to leadership and an ability to see how the company values can be truly embedded and reinforced throughout the organisation.
  • Process-based auditing experience, backed with IRCA accreditation as a Quality Auditor
  • Good understanding of ISO13485 and CE Marking under the IVDR (2017/746).
  • Good understanding of 21 CFR Part 820 and US Market Clearance via 510(k).
  • Excellent understanding of ISO14971 Risk Management.
  • Good understanding of the design and manufacture of medical device software.
  • Background in process validation, design control, design verification and validation.
Full details will be provided on application. This is a permanent role in Oxford, Oxfordshire.