Senior Quality Engineer - Validation Focus
OrganOx Limited
Join OrganOx as a Senior Quality Engineer focusing on validation strategies. Ensure powerful outcomes in medical technology through robust validation of manufacturing processes. In this critical role, positioned in the Product Quality team, you will lead all validation activities ensuring compliance with industry standards. Your tasks will include developing validation plans, analyzing risks through pFMEA, and maintaining supplier relationships while overseeing validation documentation. The role is key to enabling safe and effective medical devices delivered to patients. Key Responsibilities:
- Lead validation planning for processes and methods
- Define acceptance criteria and validation strategies
- Collaborate with teams for effective design transfer
- Supervise analysis of validation data using statistics
- Drive improvements in validation standards and procedures
- Extensive experience in validation roles, preferably in medical devices
- Proficiency in pFMEA and risk management analysis
- Strong capability in statistical validation techniques
- Degree or equivalent in engineering or biosciences
- Familiarity with FDA and international regulatory frameworks
Vacancy posted 7 days ago
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