Medical Device QMS Audit Manager

18 hours ago

Bucharest, Bucureşti, Romania SGS Full time 90,000 - 120,000 per year
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 global 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.

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