
Quality Manager Getinge Disinfection
- Växjö, Kronoberg
- Permanent
- Heltid
- Be responsible for regulatory compliance
- Act as local Management Representative
- Develop, define, maintain and revise processes, and QMS procedures to ensure company and products comply with allocable regulations and laws
- Organize and prepare management review meetings and report the performance of the QMS to local and global Executive Management
- Manage the day-to-day operations of the QA function to achieve Quality Objectives and targets
- Coordinate and host external certification and surveillance audits/inspections
- Bachelor´s degree in science or engineering
- Minimum 5 years related experience in QA in a Medical Device manufacturing environment
- Strong leadership skills and experience in leading and coaching teams
- Strong knowledge and experience in 21 CFR part 820, ISO 13485 and other related regulatory requirements
- Successful interactions and experience with regulatory agencies
- Good knowledge of statistics and practical application of the QSR and ISO 13485
Uptrail