Post Market and Complaint Analyst

Meridian Bioscience • North Billerica, MA

2d

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 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 Quality, Regulatory Affairs, Manufacturing, Engineering, Technical Support, R&D, and Operations teams to investigate product issues and customer concerns. The position also maintains complaint records in the electronic Quality Management System, supports audits and inspections, and contributes to continuous improvement initiatives.

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.
• 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 a related field.
• Familiarity with root cause analysis methodologies such as 5-Why, Fishbone Analysis, and Failure Mode and Effects Analysis (FMEA).

Responsibilities

• Receive, review, document, and process customer complaints in accordance with established procedures and regulatory requirements.
• Escalate significant product quality, safety, or compliance concerns to management.
• Investigate complaints to determine the nature, extent, and potential causes of reported product issues.
• Gather and evaluate 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 and 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, and assist in assessing field performance and product reliability trends.
• Evaluate complaints and adverse events for potential regulatory reporting requirements and support MDR, Vigilance, Adverse Event, and other post-market regulatory reporting obligations.
• Maintain complaint files and supporting records in compliance with applicable 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.
• Collaborate with relevant cross-functional teams to implement corrective and preventive actions, and verify their implementation and effectiveness.
• Ensure complaint information is incorporated into risk management and quality system processes.
• Communicate investigation findings and recommendations to internal stakeholders and contribute to continuous improvement initiatives.
• Maintain accurate and complete complaint records within the electronic Quality Management System.
• Assist in developing and revising complaint handling procedures, work instructions, and training materials.
• Participate in training and professional development, support special projects and continuous improvement initiatives, and perform other duties as assigned.

What This Job Offers

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