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.
- 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.