Company Description
Location: Remote within Europe
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,500 employees operate a network of 2,500 offices and laboratories, working together to enable a better, safer and more interconnected world.
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:
- 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.
Key Responsibilities
- Design and manage training programs for QMS Auditors, globally.
- Approve Level 1 audits and witness audits for auditor qualification and requalification.
- Contribute to recruitment, onboarding, and approval of new personnel.
- 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
Qualifications
- Education: Bachelor’s degree (or equivalent) in medicine, pharmacy, engineering, or related scientific field.
- 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 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.).
- Skills:
- 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
Additional Information
Why SGS?
- Opportunity to work with a integral leader in inspection, verification, testing, and certification.
- Collaborative and inclusive work environment.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfil your potential.
📌 Medical Device QMS Audit Manager
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