About the Role
Responsibilities
- 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
- Organize site Management Review
- Track and report KPIs
- Supplier qualification including leading of audits
- Site QARA projects
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
Ready to Apply?
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