A leading medical device company in the UK is seeking an experienced Senior Quality Engineer to ensure compliance with its Quality Management System. This role involves leading the Internal Quality Audit Programme, coordinating external audits, and delivering training to support adherence to global medical device regulations. The ideal candidate will have a relevant degree, proven experience in Quality Management Systems, and strong analytical skills. This position promises a dynamic work environment focused on quality, regulatory excellence, and continuous improvement.
Qualifikationen
Proven experience in Quality Management Systems within a medical device or similarly regulated environment.
Lead Auditor or Internal Auditor qualification with demonstrable audit experience.
Knowledge and experience with FDA regulations, MDSAP, and MDR.
Aufgaben
Lead the Internal Quality Audit Programme, performing audits according to schedule.
Coordinate preparation for external regulatory audits and inspections.
Develop and maintain processes for managing unannounced audits.
Kenntnisse
Analytical skills
Problem-solving skills
Communication skills
Facilitation skills
Coordination skills
Prioritisation skills
IT skills (Microsoft Office)
Ausbildung
Relevant Science or Engineering degree
Tools
Quality Management Systems
Microsoft Office
QA systems
Jobbeschreibung
A leading medical device company in the UK is seeking an experienced Senior Quality Engineer to ensure compliance with its Quality Management System. This role involves leading the Internal Quality Audit Programme, coordinating external audits, and delivering training to support adherence to global medical device regulations. The ideal candidate will have a relevant degree, proven experience in Quality Management Systems, and strong analytical skills. This position promises a dynamic work environment focused on quality, regulatory excellence, and continuous improvement.
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