For one of our Medical Device clients in the Brabant area of the Netherlands we are looking for a freelance QMS Audit manager. The client is being audited and needs help to ensure QMS compliance and where needed implement improvements.
Asses QMS compliance and effectiveness of the department being audited
Plan, coordinate and execute QMS audits
Reviewing the responses to the findings of the QMS audit for completeness and effectiveness
Ensure your team is following the proper audit procedures and processes in line with the company main QMS
Identify and communicate Best Practices to different departments of the company
Participate in Quality and regulatory initiatives
Provide audit coaching and training, support and drive external audit
Building relations with the Notified Bodies
Manage the pool of part time auditors
Medical Device experience, 10 years minimum
Experience as a Lead Certified Auditor, Quality Auditor or Certified Bio-medical Auditor
Knowledge of: ISO 13485 (preferably 13485:2016), ISO 14971 and 21 CFR 820
Ability to adapt to an continuously changing environment
Language: fluent in English
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