Full-Time Medical Device QMS Audit Manager
SGS is hiring a remote Full-Time Medical Device QMS Audit Manager. The career level for this job opening is Manager and is accepting Warszawa, Poland based applicants remotely. Read complete job description before applying.
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SGS
Job Title
Medical Device QMS Audit Manager
Posted
Career Level
Full-Time
Career Level
Manager
Locations Accepted
Warszawa, Poland
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Job Details
We are seeking a Medical Device QMS Audit Manager to lead and oversee the training, qualification, and compliance processes for QMS Auditors. This role ensures the competence of technical personnel and the regulatory compliance of SGS Notified Body 1639.
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.
Requirements:
- Bachelor’s degree 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.).
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
Skills
FAQs
What is the last date for applying to the job?
The deadline to apply for Full-Time Medical Device QMS Audit Manager at SGS is
29th of October 2025
. We consider jobs older than one month to have expired.
Which countries are accepted for this remote job?
This job accepts [
Warszawa, Poland
] applicants. .
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