Manager, Post Market Quality and Complaints

Meridian Bioscience, Inc. • Billerica, MA

7d • $135,000 - $175,000

About The Position

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

Requirements

• Bachelor's degree in Engineering, Quality, Biology, Microbiology, or Chemistry.
• At least 10 years of post-market surveillance experience, including 7 years of experience with a medical device manufacturer.
• At least 7 years of direct experience managing a team of professionals.
• Working knowledge of process improvement techniques.
• Strong written and verbal communication and computer skills.
• Ability to work with minimal supervision from senior management.
• Ability to effectively manage multiple and changing priorities.
• Excellent collaboration and problem-solving abilities.
• Strong knowledge of ISO standards and FDA regulations and guidance as they apply to medical devices.
• Understanding of computer validation (FDA 21 CFR Part 11) and equipment validation requirements.
• Experience handling and coordinating responses to FDA and ISO.
• Continued education to stay current with changing global requirements.

Responsibilities

• Lead and manage complaint handling and post-market activities in compliance with applicable FDA, international, and other regulatory requirements.
• Oversee 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 complaints while meeting 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 resolve problems.
• Lead complaint-data trend analysis 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.
• Serve 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.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager