Manufacturing Quality Engineer

4 days ago

Cirencester, Gloucestershire, United Kingdom Corin Group Full time
Job Description

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 be responsible for defining and developing manufacturing solutions from the early phases of New Product Introduction (NPI) through to production.

You will work closely with Design, Production, and Quality Engineers to produce relevant documentation in line with FDA and other global quality standards. Your expertise will be essential in ensuring that our manufacturing processes meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Process Development: 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 (DFM): 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: 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.
  • Technical Innovation: Brainstorming, problem-solving, and proposing technical innovation activities to support Continuous Improvement (CI).
  • Documentation Review: 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.
  • Standard Operating Procedures (SOPs): Generate Standard Operating Procedures, Work Instructions, and associated Forms to maintain the design control subsystem of the Quality Management System.
  • Process Stability and Capability: Process stability and capability reports.
  • Project Presentations: Deliver project presentations at all levels in the organization as well as to customers/suppliers, and justify CAPEX spend.
  • Mentorship and Coaching: Mentor and coaching of relevant cross-functional team members.
  • Training Documentation: Generate training documentation to support the end user.
  • First Article Inspection: Create First Article Inspection documentation.
  • CAPA Activities: Support the company's Corrective & Preventive Actions (CAPA) activities and act as a subject matter expert for the Process Engineering tasks within the assigned CAPA project.
  • Project Documentation Audits: Initiation of project documentation audits to ensure project gate readiness.
  • Quality Management System (QMS): Adhere to Quality Management System (QMS) requirements in line with Corin's ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820.

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