QA Engineer MDR

vor 3 Wochen


Basel, Schweiz Recooty Vollzeit

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%) #J-18808-Ljbffr


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