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Senior Quality Assurance Engineer
Job summary
A leading Medtech Start-up in the UK is seeking an experienced Senior Quality Systems Engineer to take ownership of the Quality Management System (QMS). This remote-based role involves ensuring compliance with global regulatory requirements, leading audits, and managing supplier oversight. The ideal candidate has 8+ years of experience in the medical device sector and a strong background in QMS implementation. Join us to play a pivotal role in ensuring patient safety and successful market access.
Benefits
Qualifications
- 8+ years' Quality/Compliance experience in the medical device or pharmaceutical sector.
- Strong leadership in QMS implementation (ISO 13485, ISO 14971, GMP).
- Proven background with design controls, risk management, supplier audits, and regulatory inspections.
Responsibilities
- Develop, implement, and maintain ISO 13485-compliant QMS.
- Lead audits, risk management, CAPA, and management reviews.
- Ensure compliance with GMP, GDP, MA requirements, and regulatory inspections.
Skills
Education
Senior Quality Systems Engineer - Medical Devices / Combination Products. On behalf of a well funded Medtech Start-up we're seeking an experienced Senior Quality Systems Engineer to take ownership of the Quality Management System (QMS) and ensure full compliance with global regulatory requirements. This is an end-to-end role covering design controls, manufacturing, supplier oversight, quality and compliance, and post-market surveillance.
- Develop, implement, and maintain ISO 13485-compliant QMS.
- Lead audits, risk management, CAPA, and management reviews.
- Oversee suppliers, CMOs/CDMOs, testing labs, and QP release activities.
- Ensure compliance with GMP, GDP, MA requirements, and regulatory inspections.
- Manage regulatory submissions, technical agreements, and product quality reviews.
- Drive continuous improvement initiatives and lead risk assessments (ISO 14971, ICH Q9).
- Degree in Pharmacy, Biomedical Engineering, Quality, or related discipline (Master's preferred).
- 8+ years\' Quality/Compliance experience in the medical device or pharmaceutical sector.
- Strong leadership in QMS implementation (ISO 13485, ISO 14971, GMP).
- Proven background with design controls, risk management, supplier audits, and regulatory inspections (MHRA/Notified Bodies).
- Experience with combination drug/device products highly desirable.
- Eligible for or working toward QP status a plus.
- Remote-based role with travel for audits, inspections, and supplier oversight.
- Competitive package and opportunity to shape quality strategy at a senior level.
- Apply today to play a pivotal role in ensuring patient safety, product compliance, and successful market access.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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