LeasingTeam Professional supports Polish and global enterprises in sourcing key talent and in human resources management. The Agency specializes in permanent recruitment for mid- and senior level positions and in white-collar outsourcing. It successfully completes recruitment projects by applying a trademark ASSET® methodology that structures recruiter activities and boosts their effectiveness. We have offices in Warsaw, Katowice, Gdansk and Wroclaw. Professional is part of LeasingTeam Group - Poland"s largest group of exclusively Polish-owned personnel consultancy companies that for the past 21 years has been effectively linking candidates with employers and providing them with a comprehensive range of HR services.
For one of our Clients, we are currently looking for: QMS Manager
Job description:
- Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 9001 and U.S. FDA requirements
- End-to-end preparation and participation in U.S. FDA registration and certification processes
- Manage and control quality system documentation and change processes
- Ensure compliance with ISO 9001 and applicable regulatory requirements
- Prepare for and participate in internal, external, customer, and regulatory audits
- Drive effective CAPA management and follow-up of quality events and deviations
- Coordinate risk assessments and support proactive quality improvement
- Prepare and support Management Reviews
- Deliver QMS onboarding and quality-related training
- Lead implementation and adoption of digital QMS/eQMS tools
- Support integration of QMS with operational excellence systems
- Support supplier qualification and supplier quality processes
Expectations:
- University degree in Quality Management, Engineering, Life Sciences, or a related field
- Experience in similiar position
- Fluent Polish and English
- Practical experience with FDA requirements
- Ability to share knowledge
- Strong organizational, analytical, and communication skills
Offer:
- Full-time role with the option of an employment contract or B2B arrangement
- Possibility of hybrid work
- Flexible working time
- Real opportunities for professional growth and skills development
- Comprehensive benefits package
- Opportunity to have an impact on the company’s operations
- Work in a friendly and open-minded environment