Medical Device QMS Audit Manager
Employment Information
Job Description
Medical Device QMS Audit Manager role at SGS overseeing training and compliance for QMS Auditors. Leading regulatory adherence and developing QMS documentation for medical devices.
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.
- Design and manage training programs for QMS Auditors, globally.
- Approve Level 1 audits and witness audits for auditor qualification and requalification.
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.).
- Deep technical knowledge of non-clinical aspects of medical device conformity assessment.
- Proven ability to develop and deliver effective training.
- Strong understanding of EU regulatory frameworks and best practice guidance.
- Excellent stakeholder engagement, problem-solving, and communication skills.
Benefits:
- Opportunity to work with a global leader in inspection, verification, testing, and certification.
- Collaborative and inclusive work environment.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
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