Walker Cole International is searching for a Senior Quality Engineer to join a Medical Device company based in South Wales. As the Senior Quality Engineer, you will be responsible for process ownership of design quality and risk management sitewide as well as approving change management activities from a risk and validation perspective.
Key responsibilities of the Senior Quality Engineer include:
1. Mentoring and overseeing validation plans, protocols, reports, and requirement specifications.
2. Working closely with R&D, clinical and operations, and other business functions to ensure quality performance of product and process.
3. Supporting internal and external audit processes.
4. Initiating and leading the development of PHAs, pFMEAs, and dFMEAs.
A successful Senior Quality Engineer will demonstrate:
1. A detailed understanding of the Medical Device manufacturing process.
2. Proficiency in ISO 13485, Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).
3. A good understanding of engineering and quality practices and methods.
4. Excellent communication skills and attention to detail.
Training in Lean Six Sigma project management approach is a distinct advantage.
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