Manager, Post Market Quality & Compliance

Synthesis Health is seeking a Post-Market Quality Manager to lead and continuously improve post-market quality processes for its Software as a Medical Device products. The role oversees complaint handling, safety and adverse-event assessment, trend analysis, CAPAs, field actions, and quality compliance in partnership with cross-functional teams.

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 execution of quality-related field actions and ensure appropriate documentation and follow-through
• Identify and communicate significant quality trends or risks for Management Reviews and to leadership
• Translate post-market regulatory requirements into actionable information; support training program to improve effectiveness of QMS training
• Provide quality guidance, mentorship and training
• Represent post-market quality in relevant product, management reviews, and audits
• Maintain and improve relevant procedures, work instructions, templates and associated quality system processes
• Support internal and external audits and provide evidence of effective post-market quality processes
• Ensure activities are conducted in accordance with applicable medical device regulations, standards and company procedures
• Support inspection readiness and respond to audit and/or regulatory observations
• Identify opportunities to simplify, automate and strengthen quality processes while maintaining compliance
• Other duties as assigned

Requirements:

• A bachelor's degree plus advanced training and certifications in MDSAP Quality Management Systems, post-market surveillance requirements of FDA, Health Canada and EUMDR
• 6+ years experience in Quality within the healthcare or life sciences industry, including internal and external audits, field corrections, adverse event reporting, data collection
• Knowledge of ISO 13485 and application in SaMD
• Knowledge of MDSAP program
• Knowledge of relevant FDA, Health Canada medical device regulations and implementation for SaMDs
• Collaborate with both technical and non-technical team members
• Quickly build trusting relationships with both internal and external stakeholders
• Adjust quickly to changing priorities
• Strong analytical and critical thinking skills
• Excellent people and management skills in interacting with staff, colleagues, cross-functional teams and third parties
• An eagerness to learn about new trends, tools, and technologies, and to continually consider how they will influence our products
• You can work in a fast-paced environment and juggle multiple projects with overlapping deadlines
• Bachelors in computer science, engineering, or a relevant discipline; Masters degree in relevant discipline
• 6+ years' experience working in quality assurance/post market quality systems for a SaMD company
• Experience working in an agile environment
• Experience applying technology tools (including AI) to improve productivity and efficiency of processes and records