Supplier Quality Engineering Manager

Nova Biomedical:
One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

This role is responsible for leading the Supplier Quality Engineering function and driving the technical quality and engineering performance of Nova Biomedical's supply base throughout product lifecycle activities, including design transfer, supplier process qualification, incoming inspection, manufacturing engineering support, engineering validation, and continuous improvement. This position partners closely with Research & Development Engineering, Manufacturing Engineering, Operations, and suppliers to ensure robust engineering processes, effective risk management, and consistent delivery of high-quality components and materials that meet product, engineering, and regulatory requirements.

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.

• 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.
• Apply engineering principles, statistical methods, and quality engineering tools to assess supplier process capability, identify sources of variation, and drive continuous improvement.
• 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.
• Lead disposition, investigation, and trend analysis of supplier-related Non-Conforming Material Reports (NCMRs) and implement systemic corrective actions.
• Issue and manage Supplier Corrective Action Requests (SCARs), ensuring sustainable engineering solutions are implemented and verified through effectiveness reviews.
• Analyze supplier quality and process engineering data to identify trends, reduce defects, improve process capability, and enhance supply chain robustness.
• Support design transfer activities by ensuring suppliers meet manufacturing, quality, engineering, and regulatory requirements before product launch.
• Evaluate supplier changes for potential impact to product quality and manufacturing engineering processes, ensuring appropriate validation and risk assessment activities are completed.
• Collaborate with suppliers to improve process controls, inspection strategies, yield performance, manufacturing efficiency, and engineering capability.
• Conduct supplier technical and engineering assessments, including on-site evaluations of manufacturing processes, process controls, validation practices, and engineering capabilities.
• Serve as the Supplier Quality Engineering subject matter expert during internal audits, regulatory inspections, and ISO 13485/MDSAP/IVDR certification audits.

• 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.
• Strong understanding 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.
• Working knowledge of statistical quality engineering tools, including SPC, process…