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Manufacturing Quality Engineer

2 months ago

Cirencester Gloucestershire, United Kingdom Corin Group Full time

Corin is seeking a Manufacturing Quality Engineer, who will define and develop manufacturing solutions from the early phases of NPI through to production working with Design, Production, and Quality Engineers to produce relevant documentation in line with FDA and other global quality standards. You will be based out of our global manufacturing site in Cirencester daily, working within the Global Quality team reporting to the Senior NPI Product and Process Quality Engineer.

We are looking for a Manufacturing Quality Engineer who has

  • Time served experience as a Production or Manufacturing engineer which includes CNC machining, measuring methodologies (CMM), and inspection techniques
  • A strong understanding of quality documentation and processes, and how they impact a manufacturing environment that is highly regulated such as ortho, medical devices, pharmaceuticals, healthcare, automotive, or aerospace.
  • A good understanding of lean manufacturing and project management principles.

The key responsibilities of the Manufacturing Quality Engineer will be to: -

  • Support the process for the end-to-end manufacture of orthopedic implants and associated instrumentation with varying degrees of manufacturing complexity within cost and time constraints.
  • Define metrology and inspection methods to support the manufacture of complex devices and systems,
  • 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.
  • 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.
  • Brainstorming, problem-solving proposing technical innovation activities to support CI
  • Review and sign off on critical design documentation, including but not limited to pFMEAs, Hazard Analysis Documents, Drawing Reviews (specifically for CTQ elements), Risk Management Plans, Control Plans, and Process Inspections Sheets, ensuring that correct documentation practices are maintained, i.e. things such as correct standard revisions, correct measurement data, manufacturing data is present Inc signatures, etc.
  • Generate Standard Operating Procedures Work Instructions and the associated Forms to maintain the design control subsystem of the Quality Management System.
  • Process stability and capability reports
  • 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.
  • Generate training documentation to support the end user
  • Create First Article Inspection documentation
  • 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 and ensure that process & timeline requirements for CAPA are met by Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives.
  • Initiation of project documentation audits to ensure project gate readiness.
  • Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820.