Manager, Post Market Quality and Complaints

Meridian Bioscience • North Billerica, MA

6d

About The Position

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

The manager leads and develops a team of post-market quality professionals, establishes departmental objectives and performance metrics, and manages resources and workload. The role partners with teams across the company and global stakeholders, presents complaint metrics and trends during Management Review meetings, and serves as a subject matter expert during audits and inspections. Other duties may be assigned.

Requirements

• Bachelor’s degree in Engineering, Quality, Biology, Microbiology, or Chemistry.
• At least 10 years of experience in post-market surveillance.
• At least 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 manage multiple and changing priorities effectively.
• Strong collaboration and problem-solving skills.
• Strong knowledge of ISO standards and FDA regulations and guidance as they apply to medical devices.
• Understanding of computer validation, including FDA 21 CFR Part 11, and equipment validation requirements.
• Experience handling and coordinating responses to FDA and ISO.
• Continued education to keep 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 involving products, instruments, and services.
• Establish departmental objectives, performance metrics, and strategic plans aligned with Quality and Regulatory Affairs priorities.
• Ensure timely complaint investigation and resolution while meeting internal procedures and regulatory reporting timelines.
• Manage, coach, develop, and evaluate a team of post-market quality professionals.
• Improve complaint-handling processes, investigation methodologies, and customer support activities.
• Review and approve investigation protocols, reports, root-cause analyses, and complaint files.
• Collaborate with Technical Support, Quality Assurance, Quality Control, Manufacturing, R&D, Engineering, Regulatory Affairs, and Commercial teams to resolve issues.
• Analyze complaint trends to identify recurring issues, emerging risks, and opportunities for product and process improvements.
• Escalate and report 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 arising from complaint investigations.
• Prepare and present complaint metrics, trends, and quality indicators at Management Review meetings.
• Serve as the complaint-handling and post-market quality subject matter expert during internal and external audits and inspections.
• Communicate 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