Manager, Post Market Quality & Compliance

Huntington, WV

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.

The ideal candidate brings strong experience with MDSAP quality systems, and post market surveillance of radiology-related SaMD products, combined with an understanding of software development, QA, cloud-based products, unique quality considerations associated with SaMD, and radiology. This role is highly hands-on and requires the ability to independently lead complex investigations and quality initiatives without direct reports.

Key Responsibilities:

• Own and continuously improve post-market quality SOPs and tools used for effective and compliant post market surveillance
• Lead assessment and investigation of product complaints, including problem definition, risk assessment, investigation strategy, root cause analysis, and resolution
• Evaluate complaints and product events for reportability, escalation and potential patient or user impact in partnership with SMEs.
• Monitor post-market quality data to identify emergent issues, adverse trends, recurring problems and opportunities for product or process improvements.
• Establish and maintain meaningful quality metrics, dashboards and management reporting
• Ensure appropriate documentation, traceability, and timely closure of post-market quality records.
• Lead complex and cross functional CAPAs arising from post-market data, complaints, audits, non-conformances and other quality signals
• Facilitate root-cause analysis using appropriate problem-solving methodologies and drive actions to completion
• Develop and oversee effective CAPAs
• Identify systemic issues and recommend improvements to products, processes, controls and the QMS
• Partner with Engineering and Product to assess software defects, anomalies, and product issues from a quality and safety perspective
• Support evaluation of software changes, including assessment of potential post-market impact and quality implications
• Participate in investigations involving software functionality, data integrity, interoperability, usability, cybersecurity, and other product specific risks as applicable
• Help establish effective interfaces between post-market quality SOPs and software development, release, change-control and risk management processes
• Lead quality compliance activities associated with product correction, removals, customer notifications, and other field actions.
• Provide QMS and regulatory compliance input into escalation decisions based on product risk, severity, frequency and available evidence
• Coordinate cross-functional…