Post-Market Quality & Complaint Investigator

Meridian Bioscience International Limited; North Billerica (MA); Sur place; USD 90 000 - 115 000; Plein temps

Résumé du poste

Meridian Bioscience International Limited in the United States is seeking a Post Market and Complaint Analyst to manage complaint handling, product quality investigations, and post-market surveillance for diagnostic products. This role ensures regulatory requirements are met and supports CAPAs to maintain product safety and quality.

You will collaborate with Quality, Regulatory Affairs, Manufacturing, and Technical Support to gather data, trend issues, and prepare reports for MDR and other

Qualifications

• Bachelor’s degree in biology, chemistry, microbiology, engineering, or a related discipline.
• 2–5 years of experience in complaint handling, post-market surveillance, quality assurance, regulatory affairs, or related field.
• Experience in regulated industries such as medical devices preferred.
• Knowledge of FDA QSRs, ISO 13485, EU MDR, and post-market surveillance requirements.
• Understanding of complaint handling, CAPA, risk management, and adverse event reporting.
• Familiarity with root cause analysis methodologies (5-Why, Fishbone, FMEA).
• Proficiency with Microsoft Office and eQMS.

Responsabilités

• Receive, review, document, and process customer complaints per procedures.
• Investigate complaints to identify causes and potential risks.
• Review device history records and quality documentation to support investigations.
• Prepare investigation summaries and closure within timelines.
• Support post-market surveillance activities and trend analysis.
• Assist with regulatory reporting including MDR and adverse event reporting.
• Collaborate with cross-functional teams to implement CAPAs.
• Maintain accurate complaint records in the eQMS.
• Participate in audits and inspections related to complaint handling.

Connaissances

Strong analytical and investigative

Excellent written and verbal comms

Attention to detail

Cross-functional collaboration

Formation

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

Outils

Microsoft Office

eQMS

Description du poste

Meridian Bioscience International Limited in the United States is seeking a Post Market and Complaint Analyst to manage complaint handling, product quality investigations, and post-market surveillance for diagnostic products. This role ensures regulatory requirements are met and supports CAPAs to maintain product safety and quality.

You will collaborate with Quality, Regulatory Affairs, Manufacturing, and Technical Support to gather data, trend issues, and prepare reports for MDR and other