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Urgent! Medical Device QMS Audit Manager Job Opening In Warsaw – Now Hiring SGS

Medical Device QMS Audit Manager



Job description

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 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.).
  • 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

  • Required Skill Profession

    Operations Specialties Managers



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