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My client, a pioneering medical devices company, is currently looking for a Senior Quality Engineer to join on a permanent basis during a period of exponential growth within the business. The Quality Engineer should be highly motivated individual with a sense of ownership to lead and perform quality engineering activities to support safe, effective and compliant development and sustainment of the organisations medical device designs and manufacturing processes
Key Job Responsibilities for this position 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.
*Raise problem reports, Non-Conformity report, Corrective Action and Preventive Actions to address product quality concerns and/or QMS concerns.
*Support legal manufacturers documentation requirements and technical enquiries to demonstrate company's state of the art regulatory solutions for applicable markets.
Qualifications / Requirements:
*Degree Qualified or equivalent: BSc (Hons.) or BEng (Hons.), ideally in an engineering or related technical discipline.
*Experience in a quality related field within a Medical Device design environment as a Quality Engineer (preferred) or Quality Engineering experience in a highly regulated sector is essential
*Experience in product and process software and hardware V&V. Previous experience in an assembly environment is important.
*Experience in product V&V in a NPI / NPD environment.
*Experience in CAPAs and NCs.
The ideal candidate must be highly proactive and results focused with the ability to influence others within the team. They need to have a proven ability to achieve business' targets and possess strong technical problem-solving skill. A self-motivated individual who can work both individually and as part of a team.
Senior Quality Engineer, Cheshire / North Wales