Quality Complaint Analyst

Responsible for the execution and maintenance of the complaint handling process by actively managing product complaints throughout their full lifecycle, from intake through investigation and closure. This role works closely with cross-functional partners, including Customer Support, Engineering, Service, and Medical/Clinical advisors, to ensure accurate documentation, timely investigations, and appropriate reportability assessments in accordance with established procedures and regulatory requirements.

Responsibilities

Contribute continuous improvements to the Complaint Handling process; Provides information for timely Adverse Event reporting; Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint; Collaborate with Customer Support, Engineering, and Service teams to support complaint activities; Perform reportability determinations in conjunction with medical advisor as necessary; Be part of the Complaint Handling Unit and cross functional team of individuals through completion of investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards; Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments; Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors; The role requires awareness of new or revised regulations and/or guidelines; Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance; Support additional Quality Systems activities, as requested; Support additional activities, as assigned

Requirements

Bachelor's degree in Biomedical Engineering, Industrial Engineering, Biotechnology, or related field; Minimum of 2 years of relevant experience in the medical device industry required, preferably in Quality Assurance, Complaint Handling, or Post-Market Surveillance; Working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable U.S. medical device regulatory requirements; Familiarity with FDA Medical Device Reporting requirements (21 CFR Part 803) and medical device complaint handling processes; Understanding of Good Manufacturing Practices (GMP), quality management systems, and documentation practices; Familiarity with complaint investigations, root cause analysis, and Corrective and Preventive Actions (CAPA); Strong analytical, problem-solving, and attention-to-detail skills; Ability to manage multiple priorities and work effectively in a fast-paced, cross-functional environment; Proficiency in Microsoft Office; Fluency in English, both written and verbal

Nice to have

Experience with electronic Quality Management Systems (eQMS); Excellent interpersonal skills; A self-starter, motivated and able to positively motivate others