Quality Engineer, Validation
On-site · Oxford, England, United Kingdom
Job Summary
Quality Engineer, Validation responsible for leading process and test method validation across manufacturing processes (injection moulding, assembly, sterilisation, packaging) and sustaining validation at suppliers. Develop and maintain validation plans aligned to product risk; lead IQ/OQ/PQ and GR&R/MSA validation activities; ensure regulatory and internal quality requirements are met. Collaborates with Design Assurance, Operations, and Suppliers; applies pFMEA to define validation scope and risk-based decisions; produces validated outputs (VMP, VSR) and supports design transfer. Requires experience in ISO 13485 and risk management, data analysis, and comprehensive documentation. On-site role in Oxford, with flexibility.
Required Qualifications
- Demonstrable experience in validation within a regulated industry (medical devices preferred)
- Experience writing validation documentation (VMP/IQ/OQ/PQ/VSR)
- Strong understanding of pFMEA and risk-based decision making
- Experience with suppliers on quality activities
- Ability to translate requirements into validation plans
- Competent in statistical analysis (capability analysis, Gage R&R)
- Clear documentation and reporting
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