Hiring: Supplier Quality Engineering Manager Company: Nova Biomedical Location: Waltham, MA Job Posted Time: 2026-09-03 10:18:46 Employment Type: Hybrid About the job Experience: •7+ years of progressively responsible engineering experience in Supplier Quality Engineering, Manufacturing Engineering, Quality Engineering, Process Engineering, or a related technical engineering role within a regulated industry. Required Skills: •If you are passionate about Supplier Quality Engineering and want to be part of a team that is shaping the future of life sciences, we would love to hear from you. Apply today! •Lead and develop a team of Supplier Quality Engineers responsible for supplier qualification, process validation, and ongoing supplier engineering performance improvement. •Provide engineering and technical oversight of supplier quality engineering activities throughout design transfer, new product introduction (NPI), manufacturing, and sustaining operations. •Partner with Research & Development Engineers, Manufacturing Engineers, Supplier Development Engineers, and Operations teams to evaluate and qualify suppliers, manufacturing processes, and critical components. •Drive Advanced Product Quality Planning (APQP) activities and risk-based engineering qualification strategies for new suppliers and components. •Lead supplier process validation and engineering qualification efforts, including IQ/OQ/PQ activities, process capability studies, and manufacturing readiness assessments. •Utilize engineering risk management principles consistent with ISO 14971 to assess supplier-related risks and implement effective mitigation strategies. •Drive engineering root cause investigations for supplier-related nonconformances using structured problem-solving methodologies such as 8D, DMAIC, Fishbone Analysis, and Five Whys. Qualifications: •Bachelor's degree in Engineering, such as Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, Chemical Engineering, or a related engineering discipline required. •Minimum of 7+ years of progressively responsible engineering experience in Supplier Quality Engineering, Manufacturing Engineering, Quality Engineering, Process Engineering, or a related technical engineering role within a regulated industry. •Previous people leadership or engineering management experience. •In-depth knowledge of manufacturing processes, process controls, validation methodologies, and engineering problem-solving techniques. •Proven engineering experience qualifying suppliers, manufacturing processes, and critical components. •Demonstrated success driving supplier defect reduction and process capability improvements using data-driven engineering methodologies. •Solid functional working knowledge of statistical quality engineering tools, including SPC, process capability analysis, DOE, sampling plans, and trend analysis. •Strong knowledge of engineering risk management principles and application of ISO 14971 in supplier and manufacturing environments. •Solid functional working knowledge of ISO 13485, MDSAP, FDA Quality System Regulation, and supplier quality requirements within medical device or life sciences industries. •Strong technical engineering communication skills with the ability to influence suppliers, engineering teams, and cross-functional stakeholders. Compensation: •$130,000 - $150,000 / year •Flexible Medical, Dental, & Vision Coverage 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!