Manager, Post Market Quality and Complaints

Reporting to the Director, Quality Assurance and Regulatory Affairs, the Manager, Post-Market Quality and Complaints is responsible for leading and managing the global complaint handling process and customer/product support activities to ensure compliance with applicable regulatory requirements, company procedures, and customer expectations. The incumbent oversees complaint investigations, post-market quality activities, trend analysis, escalation processes, and continuous improvement initiatives. This role ensures timely resolution of customer complaints, effective cross-functional collaboration, and the implementation of corrective and preventive actions to maintain product quality and customer satisfaction

• Lead and manage the Complaint Handling and Post Market activities, ensuring compliance with applicable FDA and international quality and regulations and other regulatory requirements.
• Oversee the intake, evaluation, investigation, documentation, and closure of customer complaints related to products, instruments, and services.
• Establish departmental objectives, performance metrics, and strategic plans aligned with Quality and Regulatory Affairs priorities.
• Ensure timely investigation and resolution of customer complaints while maintaining compliance with internal procedures and regulatory reporting timelines.
• Manage, coach, develop, and evaluate a team of Post market quality professionals.
• Drive continuous improvement of complaint handling processes, investigation methodologies, and customer support activities.
• Review and approve investigation protocols, reports, root cause analyses, and complaint files.
• Partner with Technical Support, Quality Assurance, Quality Control, Manufacturing, R&D, Engineering, Regulatory Affairs, and Commercial teams to facilitate effective problem resolution.
• Lead trend analysis of complaint data to identify recurring issues, emerging risks, and opportunities for product and process improvements.
• Ensure appropriate escalation and reporting of significant quality issues to senior management and regulatory authorities when required.
• Oversee post-market surveillance activities related to complaint data and customer feedback.
• Support CAPA, risk management, nonconformance, and change control processes resulting from complaint investigations.
• Prepare and present complaint metrics, trends, and quality indicators during Management Review meetings.
• Act as the subject matter expert for complaint handling and post-market quality processes during internal and external audits and inspections.
• Ensure effective communication of investigation findings, corrective actions, and lessons learned throughout the organization.
• Collaborate with global stakeholders to promote harmonization and best practices in complaint management.
• Manage departmental resources, workload prioritization, and staffing requirements.
• Other duties as assigned

• Bachelor's degree in Engineering, Quality, Biology, Microbiology or Chemistry
• Minimal 10 years Post Market Surveillance with 7 years of experience with medical device manufacturer
• At least 7 years of direct experience in managing a team of professionals
• Working knowledge of process improvement techniques.
• Strong communication (written and verbal) and computer skills. Must be able to work with minimal supervision from senior management.
• Ability to effectively manage multiple and changing priorities.
• Excellent ability to collaborate to achieve objectives and problem-solve.
• Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices.
• Understanding of Computer validation (FDA 21 CFR Part 11) and Equipment Validation requirements.
• Experience in handling and coordinating responses to FDA and ISO
• Continued education to keep up to date with changing global requirements.

Compensation Range: $135,000–$175,000/year