QA Complaint Intake Specialist

Job Title: QA Complaint Intake Specialist Job Description The QA Complaint Intake Specialist is responsible for supporting the intake, triage, documentation, follow-up, and verification of medical device complaints associated with a specific product line. This role ensures that all complaint information is accurately captured in the electronic Quality Management System (eQMS), that required information is obtained and documented, and that complaint records are complete and audit-ready for evaluation by the assigned QA Complaint Investigator within a regulated environment. Responsibilities Receive and evaluate incoming information to determine whether it qualifies as a medical device complaint in a regulated environment. Perform complaint intake and triage activities, routing or escalating cases appropriately based on established procedures and regulatory requirements. Create complete, accurate, and audit-ready complaint records in the electronic Quality Management System (eQMS) in compliance with FDA expectations. Document all relevant complaint details, including device information, event description, and supporting evidence, in a clear and traceable manner. Coordinate with internal and external stakeholders to clarify complaint details, obtain additional evidence, and gather device data and returned product information as needed. Manage multiple complaint records simultaneously, tracking case status, aging, and follow-up activities to ensure timelines and metrics are met. Review disparate inputs and documentation to identify missing, inconsistent, or unclear information and determine the follow-up required for a compliant assessment. Support QA Complaint Investigators by preparing well-structured complaint files and ensuring all necessary information is available for evaluation. Maintain accurate and organized records to support audits, inspections, and quality system reviews. Adhere to all applicable procedures, regulatory requirements, and quality standards when handling complaint information and documentation. Essential Skills 1–3 years of relevant experience in Quality Assurance, medical device or pharmaceutical documentation, customer support, or another regulated industry preferred. Proven ability to perform complaint intake and triage within a regulated medical device or similar environment. Experience creating accurate, complete, and audit-ready records in an electronic Quality Management System (eQMS) or complaint handling system. Strong skills in documentation and record building in compliance with FDA or similar regulatory requirements. Ability to manage multiple complaint records, monitor timelines, and support complaint lifecycle metrics. Proficiency in reviewing and analyzing information from multiple sources to identify gaps, inconsistencies, or unclear details. Effective cross-functional communication skills for coordinating with internal and external stakeholders. Familiarity with quality management systems and working in a regulated environment. Strong attention to detail and ability to follow established procedures accurately. Additional Skills & Qualifications Experience with electronic Quality Management Systems (eQMS), complaint handling systems, or regulated documentation is preferred. Prior experience in a medical device or pharmaceutical setting is preferred but not required. Ability to work effectively in a quality-focused, highly regulated environment. Comfort working with structured documentation, forms, and standardized templates. BS/BA degree is not required for this role. Why Work Here? You will join a quality-focused organization that operates in a highly regulated environment, offering the opportunity to build specialized expertise in complaint handling and electronic Quality Management Systems. The role provides meaningful work that directly supports patient safety and product quality, along with exposure to cross-functional collaboration across quality, operations, and other key stakeholders. You will work in a setting that values accuracy, compliance, and continuous improvement, giving you a strong foundation for long-term growth in quality and regulatory disciplines. Work Environment This is an onsite role based in San Diego, with an expectation to work on site 4–5 days per week and the possibility of one remote day. You will work in a professional office environment using electronic Quality Management Systems (eQMS) and other complaint handling and documentation tools typical of a regulated medical device setting. The work involves extensive use of computer systems, documentation platforms, and communication tools to collaborate with internal and external stakeholders. The environment