Medical Device QMS Audit Manager
Employment Information
Job Description
Medical Device QMS Audit Manager for SGS overseeing training and compliance in medical device assessments. Ensuring QMS auditors' qualification and regulatory compliance for SGS Notified Body 1639.
Responsibilities:
- Lead the development and delivery of training and qualification frameworks for technical staff (excluding clinical)
- Approve Level 1 audits and witness audits for auditor qualification and requalification
- Develop and maintain QMS documentation aligned with MDR, IVDR, NBOG, and MDCG guidance
- Ensure competence, compliance, and operational efficiency across assessment teams
- Provide technical support across SGS NB 1639 activities and contribute to business development
Requirements:
- 10+ years in the medical device industry
- 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
- Deep technical knowledge of non-clinical aspects of medical device conformity assessment
- Strong understanding of EU regulatory frameworks and best practice guidance
Benefits:
- Competitive salary
- Collaborative and inclusive work environment
- Opportunities for professional growth and development
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