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. #J-18808-Ljbffr Cypress HCM