Senior Quality Assurance Specialist

4 weeks ago


Cardiff, Cardiff, United Kingdom Walker Cole International Full time

Walker Cole International is seeking a Senior Quality Assurance Specialist to lead quality management processes for a Medical Device company in South Wales. As the Advanced Quality Engineer, you will be responsible for process ownership of design quality and risk management sitewide, approving change management activities from a risk and validation perspective.

Key responsibilities of the Senior Quality Assurance Specialist include:

  • Mentor and oversee validation plans, protocols, reports, and requirement specifications
  • Collaborate with R&D, clinical, and operations teams to ensure quality performance of products and processes
  • Support internal and external audit processes
  • Initiate and lead the development of PHAs, pFMEAs, and dFMEAs

A successful Senior Quality Assurance Specialist will demonstrate:

  • A thorough understanding of Medical Device manufacturing processes
  • Proficiency in ISO 13485, Good Distribution Practice (GDP), and Good Manufacturing Practice (GMP)
  • A good understanding of engineering and quality practices and methods
  • Training in Lean Six Sigma project management approach is a distinct advantage.

Senior Quality Assurance Specialist | Quality Management | Risk Management | Medical Device | MD | Good Manufacturing Practice | GMP | Good Distribution Practice | GDP | Lean Six Sigma | ISO 13485 | Problem Solving | PHAs | pFMEAs | dFMEAs | Design Quality | Preliminary Hazard Analysis | Process Failure Mode and Effective Analysis | Design Failure Mode and Effective Analysis



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