What you will do

Implementation and maintenance of QMS compliant with ISO 13485:2016.

Managing QMS documentation.

Managing CAPAs, non-conformances, 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:

2–3 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 problem-solving abilities and experience in root cause analysis (RCA) and corrective action/preventive action (CAPA)

Preferred:

Certified Lead Auditor within ISO 13485:2016