Are you aversatile 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.