Lead the total quality function of a plant or group of plants, ensuring compliance with quality policies, Standard Operating Procedures (SOPs), and regulations
Job Summary
Lead the total quality function of a plant or group of plants, ensuring compliance with quality policies, Standard Operating Procedures (SOPs), and regulations.
Ensure compliance with European Union Medical Device Regulation (EU MDR) 2017/745 and meet experience requirements per Medical Device Coordination Group (MDCG) 2019-07.
Join a global leader with a rich history of innovation and excellence in eye care and make a meaningful difference in the lives of patients worldwide.
Matching Summary
Lead the total quality function of a plant or group of plants, ensuring compliance with quality policies, Standard Operating Procedures (SOPs), and regulations.
Skills & Requirements
Must-have
Quality Management System implementation
EU MDR 2017/745 compliance
FDA QSRs, ISO 13485, MDD, MDR
Product sterility systems
Postmarket surveillance actions
MDSAP requirements
GxP regulations adherence
Nice-to-have
Inclusive culture
Collaborative team culture
Continuous improvement commitment
Key Requirements
Min 15 years of professional experience
5 years in a leadership role
Degree in pharmacy, engineering or relevant scientific discipline
At least one year of professional experience in regulatory affairs or quality management systems relating to medical devices