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

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