Walker Cole International is searching for an 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 and will approve change management activities from a risk and validation perspective.
Key responsibilities of the Senior Quality Engineer include:
*Mentor and oversee validation plans, protocols, reports, and requirement specifications
*Work closely with R&D, clinical and operations, and other business functions to ensure quality performance of product and process
*Support internal and external audit processes
*Initiate and lead the development of PHAs, pFMEAs, and dFMEAs
A successful Senior Quality Engineer will demonstrate:
*A detailed understanding of the Medical Device manufacturing process
*Proficiency in ISO 13485, Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP)
*A good understanding of engineering and quality practices and methods
*Excellent communication skills and attention to detail
Training in Lean Six Sigma project management approach is a distinct advantage.
Senior Quality Engineer | Validation | 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|