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Quality Engineer - South Wales
Walker Cole International is searching for a Quality Engineer to join a Medical Device company based in South Wales. As the Quality Engineer, you will be responsible for investigating issues arising from design, manufacturing, and managing remedial action.
Key responsibilities of the Senior Quality Engineer include:
- Creating Post Market Surveillance (PMS), Periodic Safety Update Reports (PSUR) and Health Hazard Evaluation (HHE) reports
- Carrying out internal and external (virtual) audits
- Lead and Drive continuous improvement efforts within the business
A successful Quality Engineer will possess:
- Knowledge of Quality tools and techniques - cause and effect diagrams, Pareto analysis, SPC, and continuous improvement techniques
- Relevant qualifications to perform ISO9001 audits
- Knowledge of Medical Device Regulation
As a Quality Engineer, you may also be required to assist in the maintenance of the Quality, Environment, Health and Safety (QEHS) and LSAS management systems.
Medical Device | QE | Quality Engineer | QA | Quality Assurance | PMS | Post Market Surveillance | Periodic Safety Update Reports | PSUR | HHE | Health Hazard Evaluation | CAPA | Corrective and Preventative Action | ISO9001 | ISO13485 | ISO14971 | Risk Assessment | SOPs | Standard Operating Procedure | MDD | MDR | FMEA |
