Complaint Handling Specialist

We are seeking a detail-oriented Complaint Handling Specialist to join our Quality Assurance team. This role supports and manages medical device complaint activities — including intake, documentation, triage, investigation, regulatory assessment, and closure — ensuring complaint files are accurate, complete, audit-ready, and compliant with internal procedures, FDA Quality System Regulation (21 CFR 820), ISO 13485, and other applicable regulatory requirements.

Key Responsibilities

• Receive, document, and triage incoming product complaints in accordance with internal procedures and applicable regulations (e.g., 21 CFR 820, ISO 13485).
• Manage assigned complaints through the full lifecycle — intake review, documentation, investigation coordination, follow-up, and timely closure.
• Conduct or support complaint investigations by gathering and reviewing information from customers, internal teams, manufacturing records, device history records, and product return evaluations.
• Evaluate complaints for reportability and support timely preparation of MDR, vigilance, or other regulatory reporting documentation, as required.
• Coordinate with cross-functional partners — Customer Care, Regulatory Affairs, Manufacturing, R&D, Clinical, and Quality Engineering — to gather information for root cause analysis, risk assessment, and complaint closure.
• Accurately log, track, update, and close complaints in the electronic complaint handling or quality management system within required timelines.
• Escalate potential serious injury, death, hospitalization, product risk, recurring issues, or CAPA triggers to Quality, Regulatory, and Management stakeholders.
• Ensure complaint files are complete, clearly documented, technically sound, and inspection-ready.
• Support complaint trending, metrics reporting, and preparation of materials for management review and continuous improvement.
• Participate in internal audits and support external regulatory inspections as needed.
• Perform other quality system duties as assigned.

Required Qualifications

• 1-2 years of experience in complaint handling, quality assurance, regulatory affairs, customer quality, or a related function within a regulated environment.
• Strong documentation skills, with the ability to write clear, accurate, and objective complaint records.
• Excellent attention to detail, organization, time management, and follow-through.
• Strong written and verbal communication skills, with the ability to collaborate across cross-functional teams.
• Ability to prioritize work and manage deadlines in a fast-paced, regulated environment.
• Proficiency in Microsoft Office (Excel, Word, Outlook).

Preferred Qualifications

• Bachelor's degree in science, engineering, healthcare, or a related field, or equivalent combination of education and experience.
• Experience in the medical device, pharmaceutical, biotechnology, healthcare, or another FDA-regulated industry.
• Familiarity with FDA Quality System requirements, ISO 13485, MDR reporting, vigilance reporting, or other post-market surveillance requirements.
• Experience using a quality management system, complaint handling system, CRM, or other electronic case management platform.
• Experience reviewing product return evaluations, manufacturing documentation, device history records, or similar technical records.
• Regulatory documentation discipline and commitment to data integrity.
• Critical thinking and the ability to assess incomplete or ambiguous complaint information.
• Sound judgment in identifying high-risk complaints and escalation needs.
• Ability to work independently while maintaining alignment with Quality, Regulatory, and operational procedures.
• Continuous improvement mindset, with the ability to identify recurring complaint themes and process gaps.