We are looking for an experienced medical device or IVD QA professional to provide support to the Senior Quality Manager at a diagnostics company in Lancashire.
Responsibilities:
- Mentor and train staff on fundamentals of IVDR and ISO 13485.
- Assess quality systems and deliver a prioritized plan that closes the gaps most likely to cause nonconformances, failed audits, or unsafe product.
- Review methods, records, and change control so test results and decisions stand up to customer, regulatory, and third-party scrutiny.
- Coach site teams through root cause and corrective action until repeat issues decline and closures stay on schedule.
- Convert complex requirements into clear procedures, training, and decision criteria that operators and lab staff can use.
- Track audit readiness, finding closure, and adoption, then adjust the engagement when results stall.
Requirements:
- Experience overseeing QA in the medical device or IVD industry.
- A good knowledge of ISO 13485 and ideally IVDR.
- Experience managing non-conformances and deviations, including investigations, root cause, and CAPA.
Quality Consultant employer: Kinetica
Join a leading healthcare company in North Yorkshire that values quality and innovation, offering a supportive work culture where your contributions directly impact patient safety. With opportunities for professional growth and development, you will be part of a dedicated team committed to continuous improvement in the medical device sector. Enjoy a collaborative environment that fosters communication and teamwork, making it an excellent place for those seeking meaningful and rewarding employment.
