Global Post-Market Quality & Complaints Manager

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

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