Complaints Engineer II

Job Summary: Analyzes, evaluates, and investigates external customer complaints in accordance with FDA, ISO, Quality System, EU MDR, and other applicable regulatory requirements. Drives complaint investigations, returned-product evaluation, adverse-event reporting support, trending, customer responses, and post-market surveillance activities and helps improve complaint processes, procedures, and team capability. Drive timely, accurate, and complete complaint and failure investigations with cross-functional teams; perform retention, decontamination, objective testing, returned-product analysis, simulation, root-cause investigation, and resolution in support of product quality and patient safety. Ensure compliance with applicable US and international complaint and adverse-event regulations, including FDA, Canadian requirements, EU MDR, Medical Device Reporting, and vigilance reporting; collaborate on reportability decisions and timely report generation. Serve as the Post-Market Surveillance subject-matter expert for assigned product lines, maintaining knowledge of product design, manufacturing, complaint rates and trends, reportability, risks, and failure modes. Collect complaint follow-up information from customers, medical professionals, field staff, Sales, Field Service, affiliates, and other stakeholders; investigate field clinical events, coordinate clinical-sample investigations, and prepare customer and field responses. Analyze and trend complaint data, convene trending meetings, present engineering failure analyses and critical information, document minutes, follow action items to closure, compile PSURs, and prepare management metrics and reports. Maintain complaint-handling procedures, support team and organizational performance indicators, provide assistance and training to team members, stay current with required training, and promote continuous improvement of complaint and post-market processes. Provide engineering expertise for complaint-investigation test equipment, including feasibility, installation, validation, qualification, layout, procurement, documentation, user training; support schedules, expenditures, and monthly reports. Knowledge, Skills and Abilities (KSA) Thorough knowledge of medical-device standards and regulations, complaint handling, Medical Device Reporting, vigilance reporting, and applicable recordkeeping requirements. Strong analytical and problem-solving skills and knowledge of laboratory procedures used to evaluate returned samples and investigate product failures. Excellent written and oral English communication and technical-writing skills, with strong presentation and training capability. Ability to interact effectively with individuals and groups at all organizational levels and with customers, medical professionals, field personnel, and affiliates. Ability to manage multiple priorities independently with accuracy, sound judgment, and close attention to detail. Proficiency with Microsoft Word, PowerPoint, and Excel; Minitab proficiency is preferred. Knowledge of complaint metrics, data analysis and trending, report preparation, investigation equipment, and validation and qualification documentation. Qualifications/ Background Experiences Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent education and experience. At least three years of experience in medical-device quality assurance or a clinical environment. At least four years of quality, complaint-investigation and resolution, or clinical experience in the disposable medical-device industry. Clinical experience or in-depth knowledge of interventional products and medical procedures is strongly preferred. ASQ certification (CQE or CQIA) is desirable. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver’s seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, sustainable solutions for patients. The salary range for this position is $76,800 - $97,000 plus a 5% target bonus. Join us, and help shape wherever we go next!