Global Post-Market Quality & Complaints Manager

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

Job summary

Meridian Bioscience International Limited seeks a Manager, Post-Market Quality and Complaints to lead global complaint handling, post-market quality activities, and regulatory compliance across devices. You will oversee investigations, trend analysis, CAPA, and cross-functional collaboration with Quality, Regulatory Affairs, Manufacturing, and R&D to ensure timely resolution and continued product quality.

This role is based in Massachusetts and offers a challenging environment with exposure to

Qualifications

• Bachelor's degree in Engineering, Quality, Biology, Microbiology or Chemistry
• 10+ years Post Market Surveillance with 7+ years in medical device manufacturing
• 7+ years of direct experience managing a team
• Strong knowledge of ISO standards and FDA regulations for medical devices
• Understanding of FDA 21 CFR Part 11 computer validation and equipment validation

Responsibilities

• Lead and manage the Complaint Handling and Post Market activities, ensuring compliance with FDA and international quality regulations
• 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 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 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

Skills

Bachelor's degree (Eng/Quality/Biology

Job description

Meridian Bioscience International Limited seeks a Manager, Post-Market Quality and Complaints to lead global complaint handling, post-market quality activities, and regulatory compliance across devices. You will oversee investigations, trend analysis, CAPA, and cross-functional collaboration with Quality, Regulatory Affairs, Manufacturing, and R&D to ensure timely resolution and continued product quality.

This role is based in Massachusetts and offers a challenging environment with exposure to