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Manufacturing Quality Engineer

2 months ago

Cirencester, Gloucestershire, United Kingdom Corin Group Full time
About the Role

Corin Group is seeking a highly skilled Manufacturing Quality Engineer to join our team. As a key member of our Global Quality team, you will play a critical role in defining and developing manufacturing solutions from the early phases of New Product Introduction (NPI) through to production.

Key Responsibilities
  • Process Development and Optimization: Support the end-to-end manufacture of orthopedic implants and associated instrumentation with varying degrees of manufacturing complexity within cost and time constraints.
  • Metrology and Inspection: Define metrology and inspection methods to support the manufacture of complex devices and systems.
  • Design for Manufacturing and Quality: Ensure Design for Manufacturing (DFM), Design for Quality (DFQ), and Design for Assembly (DFA) design for quality activities and work to develop a capable and robust/stable process.
  • Process Engineering and CAPA: Self-manage the Process Engineering phase of a project within the orthopedic field where the manufacturing process is characterized by high process complexity, risk, and innovation; this includes CAPA projects as well as NPI projects.
  • Technical Innovation and Problem-Solving: Brainstorming, problem-solving, proposing technical innovation activities to support Continuous Improvement (CI).
  • Documentation and Training: Review and sign off on critical design documentation, including but not limited to pFMEAs, Hazard Analysis Documents, Drawing Reviews (specifically for Critical to Quality elements), Risk Management Plans, Control Plans, and Process Inspection Sheets, ensuring that correct documentation practices are maintained. Generate Standard Operating Procedures, Work Instructions, and associated Forms to maintain the design control subsystem of the Quality Management System. Generate training documentation to support the end user.
  • Project Management and Communication: Deliver project presentations at all levels in the organization as well as to customers/suppliers, and justify CAPEX spend. Mentor and coaching of relevant cross-functional team members.
  • Quality Management System and Compliance: Adhere to Quality Management System (QMS) requirements in line with Corin's ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820.