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.