Senior RAQA Specialist (fixed-term contract until the end of 2026)
Senior RAQA Specialist (fixed-term contract until the end of 2026)
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Job Description
What you will do
Implementation and maintenance of QMS compliant with ISO 13485:2016.
Managing QMS documentation.
Managing CAPAs nonconformances complaints and other quality related activities.
Managing suppliers.
Lead internal audits.
Support external audits for ISO 13485:2016 certification.
Cooperating with operations and post market surveillance team.
Representing quality assurance and quality management within the business.
What you need
Required:
23 years of experience in the medical device industry
Knowledge of medical device quality management systems and regulatory compliance
English and Polish full professional proficiency
Knowledge of documentation lifecycle risk assessment and change management
Strong problemsolving abilities and experience in root cause analysis (RCA) and corrective action/preventive action (CAPA)
Preferred:
Certified Lead Auditor within ISO 13485:2016
Required Experience:
Senior IC
Employment Type
Full-Time
