Walker Cole International is seeking an Advanced Quality Engineer (AQE) Manager to join a growing Medical Device Company in Southern Wales. As the Advanced Quality Engineer Manager, you would be responsible for leading initiatives and projects to enhance quality performance within the business.
The Advanced Quality Engineer Manager will be responsible for:
*Establishing and maintaining design and clinical-focused QMS Standard Operating Procedures.
*In partnership with the R&D team, drive the completion of final design verification and validation reports.
*Review and approve change management activities from a risk and validation perspective.
A successful Advanced Quality Engineer Manager will have:
*Bachelor’s degree in science, engineering, or equivalent subject
*Prior experience in a regulated environment having worked with ISO9001/ ISO13485/ ISO14971/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.
Advanced Quality Engineer Manager | AQE | ISO9001 | ISO13485 | Good Manufacturing Practice | GMP | Good Distribution Practice | GDP | Root Cause Analysis | ISO14971 | Lean Six Sigma | pFMEA | dFMEA | Risk Management | Product development | RCA | SOP | Management | QMS |