Post Market and Complaint Analyst

Meridian Bioscience, Inc. • Billerica, MA

3d • $90,000 - $115,000

About The Position

The Post Market and Complaint Analyst manages complaint handling, product quality investigations, post-market surveillance activities, and regulatory reporting support for medical device and diagnostic products. The role ensures customer complaints are evaluated, investigated, documented, and trended in accordance with applicable regulatory requirements, company procedures, and quality standards. It contributes to identifying product quality issues, supporting risk assessments, monitoring product performance in the field, and facilitating corrective and preventive actions to maintain product safety, quality, and regulatory compliance.

The analyst works with internal teams to investigate product failures, field issues, and customer concerns; communicate findings and recommendations; and support continuous improvement of complaint handling and post-market surveillance processes. The position also maintains complaint records in the electronic Quality Management System and supports audits, inspections, procedure updates, and training materials.

Requirements

• Bachelor’s degree in Biology, Chemistry, Microbiology, Engineering, or a related discipline.
• 2 to 5 years of experience in complaint handling, post-market surveillance, Quality Assurance, Regulatory Affairs, or a related discipline.
• Knowledge of FDA Quality System Regulations, ISO 13485, EU MDR, and post-market surveillance requirements.
• Understanding of complaint handling, CAPA, risk management, and adverse event reporting processes.
• Familiarity with root cause analysis methodologies such as 5-Why, Fishbone Analysis, and Failure Mode and Effects Analysis (FMEA).
• Strong analytical and investigative skills.
• Proficiency with Microsoft Office applications and electronic Quality Management Systems (eQMS).
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational abilities.
• Ability to manage multiple priorities and work effectively in a cross-functional environment.

Nice To Haves

• Experience in a regulated industry such as medical devices or another related field.

Responsibilities

• Receive, review, document, and process customer complaints according to established procedures and regulatory requirements.
• Escalate significant product quality, safety, or compliance concerns to management.
• Conduct complaint investigations to determine the nature, extent, and potential causes of reported product issues.
• Gather and evaluate complaint information from customers, technical support personnel, manufacturing records, service reports, and returned product analyses.
• Review Device History Records, production records, and quality documentation to support investigations.
• Document investigation results and prepare complaint investigation summaries and conclusions.
• Ensure complaints are processed and closed within established timelines and quality system requirements.
• Support post-market surveillance activities for commercialized products.
• Monitor customer feedback, complaint data, adverse events, service records, and product performance information.
• Perform complaint trending and statistical analysis to identify recurring issues, emerging risks, and opportunities for improvement.
• Prepare periodic post-market surveillance reports, metrics, and management review summaries.
• Assist in assessing field performance and product reliability trends.
• Evaluate complaints and adverse events for potential regulatory reporting requirements.
• Support Medical Device Reporting, vigilance reporting, adverse event reporting, and other post-market regulatory obligations.
• Maintain complaint files and supporting records in compliance with applicable FDA, EU MDR, Health Canada, and other international regulatory requirements.
• Participate in audits, inspections, and regulatory inquiries related to complaint handling and post-market surveillance.
• Participate in product risk assessments associated with complaint investigations and post-market findings.
• Support identification and escalation of significant quality and safety concerns.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering, and Technical Support teams to implement corrective and preventive actions.
• Verify implementation and effectiveness of assigned corrective actions.
• Ensure complaint information is incorporated into risk management and quality system processes.
• Partner with Technical Support, Regulatory Affairs, Manufacturing, R&D, Engineering, and Operations teams to resolve product performance issues.
• Support investigations involving product failures, field issues, and customer concerns.
• Communicate investigation findings and recommendations to internal stakeholders.
• Contribute to continuous improvement initiatives related to complaint handling and post-market surveillance processes.
• Maintain accurate and complete complaint records within the electronic Quality Management System.
• Support internal and external audits and regulatory inspections.
• Assist in developing and revising complaint handling procedures, work instructions, and training materials.
• Ensure compliance with company quality policies and applicable regulatory requirements.
• Participate in training and ongoing professional development related to complaint handling, post-market surveillance, and regulatory requirements.
• Support assigned special projects and continuous improvement initiatives.
• Perform other duties as assigned.

What This Job Offers

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