Senior Quality Engineer
Aurora Lifesciences are seeking an experienced Senior Quality Engineer to join a exciting medical device manufacturing team. The role will provide hands-on quality engineering support across manufacturing, validation, design changes, non-conformance investigations, risk management and continuous improvement. The Senior Quality Engineer will be expected to take ownership of complex quality issues, lead root cause investigations and work cross-functionally to implement robust, sustainable corrective actions. Strong problem-solving capability is essential, with Six Sigma experience highly desirable, particularly candidates comfortable using structured problem-solving and continuous improvement methodologies. Senior Quality Engineer Key Responsibilities Lead investigations into NCRs, non-conformances, CAPAs and manufacturing quality issues. Drive root cause analysis and corrective/preventive actions using structured problem-solving techniques. Support manufacturing and engineering teams with process development, process optimisation and process qualification. Create, review and approve validation protocols and reports covering IQ/OQ/PQ, design verification, process validation and Gage RandR. Review and approve design changes and provide quality engineering input into new and existing manufacturing processes. Lead risk management, PFMEA and cross-functional improvement activities. Support internal and supplier audits and ensure manufacturing activities remain compliant with ..... full job details .....
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