Medical Device QMS Audit Manager
Employment Information
Job Description
Medical Device QMS Audit Manager leading training and compliance for QMS Auditors at SGS. Overseeing regulatory conformity and technical guidance in the medical device industry across Europe.
Responsibilities:
- Lead the development and delivery of training and qualification frameworks for technical staff (excluding clinical)
- Establish and maintain competence criteria, monitor qualification status, and approve audit and assessment activities
- Provide expert technical guidance across the entire conformity assessment process and contribute to the development of QMS documentation aligned with EU regulations and best practices
- Support operational, technical, and strategic initiatives to maintain the integrity and effectiveness of SGS medical device services
- Work closely with the Medical Devices Management Team to stay abreast of regulatory changes and align internal processes accordingly
Requirements:
- Bachelor’s degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field
- 10+ years in the medical device industry, including at least 5 years in R&D or manufacturing roles
- Minimum 4 years working within a Notified Body
- Minimum 2 years leadership experience
- Prior qualification as a Lead Auditor under MDR and/or IVDR
- Strong background in QMS auditing, technical file assessment, and applicable standards (ISO 13485, ISO 14971, etc.)
Benefits:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and inclusive work environment
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