Manager, Post Market Quality and Complaints

Meridian Bioscience Inc.; North Billerica (MA); On-site; USD 135,000 - 175,000; Full time

Job summary

Meridian Bioscience Inc. seeks a Manager for Post-Market Quality and Complaints to lead global complaint handling and customer support, ensuring compliance with FDA and ISO requirements.

You will oversee investigations, CAPA, trend analysis, escalation, and cross-functional collaboration to sustain product quality and customer satisfaction. Reporting to the Director of Quality Assurance and Regulatory Affairs, you will manage a team, set objectives and metrics, drive continuous improvement, and

Qualifications

• Bachelor's degree in Engineering, Quality, Biology, Microbiology or Chemistry.
• Minimum 10 years Post Market Surveillance with 7 years of experience at a medical device manufacturer.
• At least 7 years of direct team management experience.
• Strong knowledge of ISO standards and FDA regulations for medical devices.
• Experience with FDA 21 CFR Part 11 and validation concepts.

Responsibilities

• Lead and manage complaint handling and post-market activities across the globe.
• Oversee intake, evaluation, investigation, documentation and closure of complaints.
• Establish objectives, metrics, and plans aligned with QA and Regulatory priorities.
• Ensure timely investigations and regulatory reporting as required.
• Coach and develop a team of post-market quality professionals.
• Drive CAPA, risk management and change control from investigations.
• Collaborate with cross-functional teams to resolve issues and drive improvements.
• Present complaint metrics and trends at Management Review.

Skills

Post-Market Surveillance

Team Leadership

ISO & FDA knowledge

Process Improvement

Communication Skills

Prioritization

Cross-functional Collaboration

Audit Support

Education

Bachelor's degree in Engineering, Quality, Biology, Microbiology or Chemistry

Job description

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

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

Key Duties

• 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
  
  
  

Qualifications

• 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