Hiring: Senior Quality Engineer Company: Nova Biomedical Location: Billerica, MA Job Posted Time: 2026-09-03 10:18:46 Employment Type: Hybrid About the job Experience: •8+ years Medical Device/IVD Experience as a Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company. Required Skills: •Provide expertise and general oversight for the management of Nova Biomedical's Quality Systems, including quality planning, quality control planning, internal auditing, inspection procedures, document controls, change management, process controls, quality records, corrective and preventive activities, validations, and data management. •Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions. •Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate. •Format, manage and maintain Quality Control Plans and PFMEAs for new and existing products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing and that any significant process updates are properly reflected. •Support Quality Plan activities in support of company projects. •Design and validate queries and reports for data from Production, Non-Conforming Materials, Field Return Investigation, and Corrective & Preventive Actions on the Database. •Analyze data and generate reports to identify trends and to draw effective conclusions. •Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements. Qualifications: •Bachelor's degree or higher in Engineering or the technical sciences, or equivalent experience. •Strong working knowledge of ISO13485, ISO14971, MDSAP, and FDA Regulations (21CFR Part820). •Thorough understanding of data trending techniques, and previous experience developing product and process trends and reporting to senior management. •Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC). •Excellent oral and written communication skills, prioritization, and multi-tasking skills. •Knowledge of manufacturing processes and their associated risk to product. •Detail-oriented, able to read and interpret technical documents. •Work 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. Compensation: •$125,000 - $135,000 / 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!