Senior Quality Assurance Manager

4 weeks ago


Cardiff, Cardiff, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

Walker Cole International Ltd is seeking a Senior Quality Assurance Manager to play a vital role in enhancing quality performance within their growing Medical Device Company in Southern Wales.

Responsible for leading initiatives and projects, the Senior Quality Assurance Manager will establish and maintain design and clinical-focused QMS Standard Operating Procedures.

Key responsibilities include:

  • Establishing and maintaining design and clinical-focused QMS Standard Operating Procedures.
  • Driving the completion of final design verification and validation reports in partnership with the R&D team.
  • Reviewing and approving change management activities from a risk and validation perspective.

A successful Senior Quality Assurance Manager will have:

  • Bachelor's degree in science, engineering, or equivalent subject.
  • Prior experience in a regulated environment having worked with ISO 9001/ ISO 13485/ ISO 14971/ Good Manufacturing Practice (GMP).
  • Excellent communication skills and attention to detail.

Outstanding candidates with a passion for working in a project team, committed to playing a vital role in achieving team-based targets. Prior training in Lean Six Sigma is a distinct advantage.

Senior Quality Assurance Manager | Quality Assurance | ISO 9001 | ISO 13485 | Good Manufacturing Practice | GMP | Root Cause Analysis | ISO 14971 | Lean Six Sigma | pFMEA | dFMEA | Risk Management | Product development | RCA | ...



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