Quality Engineer

Overview Quality Engineer (Complaints & Investigations) - We are seeking a Quality Engineer to support complaint handling, technical investigations, and failure analysis within a regulated medical device environment. This role is highly cross-functional, working closely with Customer Service, Engineering, Manufacturing, Regulatory, and Clinical teams to ensure timely and compliant resolution of technical issues. The ideal candidate will bring strong problem-solving skills, knowledge of medical device regulations, and the ability to communicate complex technical findings in a clear, concise way. Responsibilities Troubleshoot escalated cases from Customer Service and provide timely feedback to internal stakeholders. Support complaint processing and closure by gathering data, conducting investigations, and documenting findings. Perform or coordinate failure analysis of returned devices and potential field issues using testing, lab processes, and data analysis. Collaborate with Engineering, Quality, and other investigation teams to identify root cause and corrective actions. Maintain compliance with FDA, ISO, and EU MDR requirements throughout the complaint handling process. Prepare documentation that translates technical investigations into clear reports understandable by non-technical reviewers. Support internal and external audits related to complaint handling activities. Stay current with evolving global regulatory standards impacting complaint handling and post-market quality. Qualifications Bachelor’s degree in Engineering or a Scientific discipline (preferred). 1–2 years of experience in medical device complaint handling, quality engineering, or related technical support. Familiarity with regulations and standards including 21 CFR 820, 21 CFR 803, ISO 13485, ISO 14971, and EU MDR 2017/745. Experience working in a GMP and/or ISO-regulated environment. Strong technical writing skills, with the ability to translate investigations into clear documentation. Proficiency with MS Office (Outlook, Word, Excel, PowerPoint); experience with complaint handling or quality system databases a plus. Strong problem-solving and troubleshooting skills, with the ability to manage multiple cases simultaneously. Ability to work effectively in a cross-functional team environment. Details Seniority level: Associate Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing #J-18808-Ljbffr