Manager, Post Market Quality & Compliance

Who We Are 

We’re a mission and values driven company with tremendous dedication to our customers. Our 100% remote team, spread across the US and Canada, is dedicated to a common goal – to revolutionize healthcare through innovation, collaboration, and commitment to our core values and behaviors.  

 

About the Opportunity 

Synthesis Health is looking for a stellar Senior Post-Market Quality Manager who will be responsible for leading, implementing and continuously improving the post-market quality processes and program for the Company’s Software as a Medical Device (SaMD) products. 

The role provides quality leadership across the full post-market life cycle including complaint handling, adverse event assessment, trend analysis, nonconformances, CAPA, field actions, quality monitoring, and recalls.  The role also leads the Safety Committee that evaluates and investigates identified safety and potential compliance issues with non-medical device products.  The position partners closely with Regulatory Affairs, Chief Medical Officer, Product, Engineering, and Customer Support/Service and other cross-functional teams to ensure timely identification, investigations, escalation, and resolution of product quality and safety issues. 

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