Senior Quality Auditor & Compliance Lead

Terumo Aortic; Inchinnan; On-site; GBP 50,000 - 70,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical skills

Problem-solving skills

Communication skills

Facilitation skills

Coordination skills

Prioritisation skills

IT skills (Microsoft Office)

Education

Relevant Science or Engineering degree

Tools

Quality Management Systems

Microsoft Office

QA systems

Job description

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.