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Sr. Quality And Regulatory Affairs Manager
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Full-time
- We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
- This role will evolve along with the company QMS as the company develops and commercializes new products and gains approval to market in various geographic markets.
- Manages Quality personnel(s) which may include individuals whose functions include Quality Engineering, Document Control, Incoming Inspection, Quality Assurance Testing, Calibration, Validation, and other related responsibilities
- Ensures required quality procedures are established including CAPA, Non-Conforming Product, Risk Management, Post-market-surveillance, Purchasing Controls, Management Review, Traceability, Employee Controls, Post market management, Change Control, Advisory Notifications, Supplier compliance and others as coordinated within the Quality team and with other cross-functional departments
- Develops and conducts training on key quality topics and best practices including Root Cause Investigations, CAPA investigations, Management Responsibility, GMP/GDP, Audit Readiness, and Validation
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