Supplier Quality Engineer – Highly Regulated Electronics (Medical)
Company: Join a dynamic team at a leading medical device company based out of London and Oxford.
They are looking for a Supplier Quality Engineer to join their growing business that is transforming the lives of patients through next‑generation medical technologies, developing highly regulated electronic systems for medical applications.
Key Responsibilities
- Own and drive the supplier management programme, including onboarding, evaluation, and performance monitoring of suppliers supporting highly regulated electronic manufacturing.
- Conduct supplier audits (remote and on‑site, UK & international) ensuring compliance with quality and regulatory standards.
- Manage supplier quality agreements and lead supplier corrective actions (SCARs), ensuring timely and effective resolution of issues.
- Work closely with R&D and Manufacturing Engineering teams to support supplier selection, development, and process improvements.
- Ensure supplier processes meet required standards for validation, control, and traceability (IQ/OQ/PQ, Cp/Cpk).
- Support design‑for‑manufacture activities for complex electronic assemblies, alongside risk management and root cause investigations.
- Ensure compliance with ISO 13485 and other applicable standards within a highly regulated electronics and medical device environment.
Qualifications and Skills
- Degree in Engineering (Mechanical, Biomedical, Electrical, Electronic, or related field).
- Proven experience in supplier quality management within a highly regulated environment (e.g. Medical devices, aerospace, defence, or regulated electronics).
- Strong experience in supplier auditing and supplier corrective action management (SCARs).
- Ability to interpret engineering drawings, PCB‑related specifications, tolerances, and manufacturing documentation.
- Experience with CAPA, non‑conformance, complaint handling, and change control systems.
- Knowledge of ISO 13485 and other regulated quality system standards is highly desirable.
If you're ready to join our clients dynamic team and contribute to the advancement of medical technology, please submit your CV and cover letter to ndrain@redlinegroup.Com.
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