Supplier Quality Engineer - Highly Regulated Electronics (Medical)
Location: Didcot Oxfordshire (Hybrid)
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.
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