QA Engineer MDR

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 organization under MDR regulation
• 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%)