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: 90%: Quality Management- 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.
10 %: Other duties as assigned- Other duties as assigned.
About the Right Candidate You can work in a fast-paced environment and juggle multiple projects with overlapping deadlines.
Qualifications - 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.
- Knowledge of EUMDR
- 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.
Preferred Qualifications - 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
Compensation and Benefits Compensation is paid in the currency of the country where the individual is hired. For this position, the salary range is
$100,000 - $120,000 USD. Other benefits include but not limited to: Medical, Dental, Vision, "Use as needed" vacation policy, and participation in our employee option program.
