Hiring: Senior Quality Engineer Company: Nova Biomedical Location: Norwood, MA Job Posted Time: 2026-09-11 10:18:46 Employment Type: Hybrid Target Skills & Keywords : R About the job Required Skills: •Develop plans to resolve quality issues and use communication and analytical skills to generate support for changes. Effectively communicate with leadership to weigh pros and cons of changes and present solutions that meet business and quality/compliance needs. •Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions. •Design and validate queries and reports for data from Production, Non-Conforming Materials and Corrective and Preventive Actions on the Database. •Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate. •Format, manage and maintain Quality Control Plans and PFMEAs for new products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing. •Review and analyze specifications relating to acceptance activities. •Support Quality Plan activities in support of company projects. •Analyze data and generate reports to identify trends and to draw effective conclusions. Qualifications: •Bachelor's degree or higher in Engineering or the technical sciences •7 plus years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company. •Knowledge of regulations and standards affecting IVDs and Medical Devices (ISO 9001, ISO 13485, & ISO 14971, IVDR) and the ability to interpret regulations and apply appropriately •Excellent oral and written communication skills, prioritization, and multi-tasking skills •Detail-oriented, able to read and interpret technical documents •Works well with multi-disciplined team and understand task requirements •Demonstrated capacity to exercise judgement in selecting methods and techniques for obtaining results •Computer literacy including MS Word, MS Excel MS Access •Statistical Software experience, i.e. Minitab •Previous experience working with Master Control and/or Power BI a plus Compensation: •$110,000 - $130,000 / year 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!