Job Description
We are seeking a knowledgeable and driven Medical Device QMS Audit Manager to lead and oversee the training, qualification, and compliance processes for QMS Auditors involved in our medical device conformity assessments. This non-clinical role plays a vital part in ensuring the competence of technical personnel and the continued regulatory compliance of SGS Notified Body 1639.
Your Mission
As Technical Team Manager, you will:
1. Lead the development and delivery of training and qualification frameworks for technical staff (excluding clinical).
2. Establish and maintain competence criteria, monitor qualification status, and approve audit and assessment activities.
3. 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.
4. Support operational, technical, and strategic initiatives to maintain the integrity and effectiveness of SGS medical device services.
5. Work closely with the Medical Devices Management Team to stay abreast of regulatory changes and align internal processes accordingly.
Key Responsibilities
6. Design and manage training programs for QMS Auditors, globally.
7. Approve Level 1 audits and witness audits for auditor qualification and requalification.
8. Contribute to recruitment, onboarding, and approval of new personnel.
9. Develop and maintain QMS documentation aligned with MDR, IVDR, NBOG, and MDCG guidance.
10. Ensure competence, compliance, and operational efficiency across assessment teams.
11. Provide technical support across SGS NB 1639 activities and contribute to business development
Qualifications
12. Education: Bachelor’s degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field.
13. Experience: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 experiencePrior qualification as a Lead Auditor under MDR and/or background in QMS auditing, technical file assessment, and applicable standards (ISO 13485, ISO 14971, etc.).
14. Skills:Deep technical knowledge of non-clinical aspects of medical device conformity ability to develop and deliver effective understanding of EU regulatory frameworks and best practice guidance.Excellent stakeholder engagement, problem-solving, and communication skills