Senior Quality Engineer – Warwickshire
Senior Quality Engineer required by a medical device manufacturer to support and take ownership for the requirements through the design and development process working closely with internal departments, customers, and suppliers/other companies to understand, plan and execute the design and development stages.
As Senior Quality Engineer responsibilities include:
- Establish, implement, and promote; quality planning, design control, process control, verification, and validation activities to aid delivery of efficient designs and processes providing safe, effective, and compliant medical devices.
- Review and approve product and process documentation throughout entire product lifecycle to ensure compliant, effective, and suitably robust design solutions are fully documented.
- Raise problem reports, non-Conformity report, Corrective Action and Preventive Actions to address product quality concerns and/or QMS concerns.
- Ensure risk management process is effective and robust in identifying product and process risks and that risk mitigations are implemented so as to ensure safe and compliant medical devices.
Qualifications/ Experience required:
- Graduate or equivalent calibre in engineering, science, or technology discipline.
- Experience in a quality related field within a Medical Device design environment or equivalent regulatory controlled environment (product development).
- Experience in product and process software and hardware V&V.
- Experience in control of clean rooms for manufacture.
- Sound understanding of risk management techniques including FMEA.
Be part of something BIG and benefit from working with a progressive company delivering life support devices.
Keywords: Quality; Engineer; Medical Device; QMS; FMEA
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