Hiring: Quality System Engineer Company: Infraredx, a Nipro Company Location: Bedford, MA Job Posted Time: 2026-09-15 12:03:49 Target Skills & Keywords : Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Project Management About the job Experience: •2-5 years of relevant experience in medical device industry •5 years of relevant experience in medical device industry Required Skills: •Execution and coordination of activities associated with Nipro Vascular Innovations Americas' •Complaints process, including complaint administration and record management, investigations, reporting, as well as metrics and trending. •Compose Monthly Complaints Meeting materials and present to Senior Leadership team. •Coordinate with cross-functional team where necessary, understanding how to best leverage resources and functions within each business unit throughout the organization in order to succeed. •Perform risk assessments utilizing released product risk documentation such as PFMEAs and UFMEAs. Ability to identify gaps in current documentation while providing constructive feedback necessary for modifications. •Use data driven approach throughout all aspects of role and decision making processes, including evaluation of product performance. Approach shall remain consistent regardless of stated objectives and/or goals. •Gather information from all available sources to make timely reporting decisions, including ability to interpret clinical data and customer feedback. Demonstrated understanding of system functionality, allowing engineer to work in independent fashion, utilizing SMEs only when necessary. •Write customer letters to inform users about Best Practices or Instructions for Use as needed. Qualifications: •Bachelors in Engineering, Biomedical Science, or technical degree preferred, with 2-5 years of relevant experience in medical device industry •Knowledge of Quality System Standards and regulations including ISO 9001, ISO 13485, and QSR •Strong written/verbal communication and project management skills •Strong analytical, deductive reasoning and listening skills •Must be able to communicate precisely and accurately to all levels of the organization •Proficiency with Microsoft Office – Word, Excel, PowerPoint and Access experience required Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!