Quality Systems Manager

4 weeks ago


Berlin, United States Insight Global Full time

Our medical device manufacturing client is looking for a Quality Systems Manager to join the team The position will be responsible for ensuring global operational adherence and compliance to the company Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches. The essential functions of the role include internal auditing, CAPA, supplier quality management, documentation control, complaints investigations, and nonconforming material control to ensure all three sites are running smoothly. Oversite of the three locations will require quarterly travel. Quality certifications (ASQ CQE, QCI, etc.)4+ years' experience within a regulated manufacturing environment3+ years in a Leadership level role (budget & decision making authority)Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to GMPStrong communication skills



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