Post-Market Quality & Complaints Analyst

Meridian Bioscience International Limited; Billerica (MA); On-site; USD 90,000 - 115,000; Full time

Job summary

Meridian Bioscience International Limited in the United States seeks a Post Market and Complaint Analyst to manage complaint handling, product quality investigations, post-market surveillance, and regulatory reporting support for medical device and diagnostic products.

You will evaluate and document complaints, trend data, and support CAPAs while coordinating with Quality, Regulatory Affairs, Manufacturing, and Technical Support to maintain safety and compliance.

Qualifications

• Bachelor’s Degree required for related discipline.
• 2–5 years in Complaint handling, post-market surveillance or QA.
• Regulated industry experience preferred (Medical device or similar).
• Knowledge of FDA QSR, ISO 13485, EU MDR, post-market surveillance.

Responsibilities

• Receive, review and document customer complaints per procedures and regulations.
• Investigate complaint causes and document results with summaries.
• Trend complaints and perform post-market surveillance analyses.
• Support regulatory reporting (MDR, adverse events) as needed.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, and Technical Support.

Skills

Analytical skills

Communication skills

Cross-functional collaboration

Regulatory awareness

Education

Bachelor’s Degree in Biology, Chemistry, Microbiology, Engineering or related discipline

Job description

Meridian Bioscience International Limited in the United States seeks a Post Market and Complaint Analyst to manage complaint handling, product quality investigations, post-market surveillance, and regulatory reporting support for medical device and diagnostic products.

You will evaluate and document complaints, trend data, and support CAPAs while coordinating with Quality, Regulatory Affairs, Manufacturing, and Technical Support to maintain safety and compliance.