QA Engineer MDR
Vor 5 Tagen
- Build and maintain certified MDR Quality Management System
- Lead product registration process with Notified Body
- Represent the QMS as deputy PRRC
- Maintain local training compliance
- Lead and participate in internal audits
- Provide Quality related trainings
- Track and report KPIs
- Supplier qualification including leading of audits
Skills Required:
- Bachelor’s degree in Life Science or equivalent
- Minimum of 5 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
- Record of success and broad understanding of contemporary quality practices as they apply to product development, manufacturing, and commercial operations
- Proven expertise in the design and implementation of quality processes in world-class medical device manufacturing
- Expertise in MDR, cGMP and other Regulatory compliance requirements
- Experience in software development in the medical device context
- Self-confidence and the ability to work with all levels of organization
- Operates in a way that never compromises ethics and integrity
- Advanced leadership skills
- Ability to understand and adapt to different cultures and market needs
- (Inter-)national travel as required by business (up to 10%)
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