Manager, Post Market Quality & Compliance

Synthesis Health•Huntington, WV

5d•Remote

About The Position

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.

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.
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.
Adhere to our company’s values and behaviors and incorporate them in your interactions with colleagues and customers.

Nice To Haves

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

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