Supplier Quality Engineer (onsite)

What You Will Do

• Manage quality performance for an assigned group of suppliers and serve as a key point of contact for supplier quality matters.
• Monitor supplier performance using quality data, dashboards, scorecards, and key performance indicators.
• Communicate emerging risks, performance concerns, and improvement priorities to suppliers and internal stakeholders.
• Investigate supplier-related issues affecting incoming inspection, manufacturing, installation, and field service.
• Coordinate rapid containment and risk-mitigation activities to protect production, customers, and patients.
• Lead or support root cause investigations and Supplier Corrective Action Requests using structured problem-solving methods such as 8D, 5 Whys, Ishikawa diagrams, and statistical analysis.
• Review supplier corrective actions to confirm that root causes have been identified, appropriate actions have been implemented, and recurrence has been effectively prevented.
• Support Qnote/NCR and Material Review Board activities involving supplier-provided components.
• Help minimize production disruption, blocked inventory, scrap, rework, warranty costs, and field impact.
• Work with suppliers to improve manufacturing processes and implement appropriate quality controls, including PFMEA, Control Plans, Statistical Process Control, Measurement System Analysis, process capability analysis, Cpk/Ppk, and process validation.
• Support Quality at the Source (“light” PPAP) by helping suppliers move from reliance on inspection toward prevention, process control, and data-driven validation.
• Participate in New Product Introduction and design-transfer activities.
• Partner with Engineering and suppliers to review drawings, specifications, tolerances, critical attributes, manufacturability requirements, and inspection strategies.
• Support supplier readiness through First Article Inspection, PPAP, APQP, inspection planning, and other qualification activities based on product and process risk.
• Review Supplier Change Notifications involving materials, manufacturing processes, equipment, tooling, sub-tier suppliers, quality systems, or manufacturing locations.
• Coordinate with Engineering, Procurement, Manufacturing, Regulatory Affairs, Service, and other stakeholders to evaluate supplier changes and ensure required qualification and validation activities are completed before implementation.
• Conduct or participate in supplier audits, process assessments, supplier qualifications, and for-cause investigations. Document findings and track corrective actions through effective closure.
• Partner with Service and other functions to review field-performance and warranty data, identify supplier-related trends, and drive appropriate investigations and corrective actions.
• Analyze non-conformance, scrap, rework, warranty, and operational data to identify opportunities to reduce defects and Cost of Poor Quality.
• Participate in cross-functional forums to support timely decisions and resolution of supplier-related issues.

What You Will Have

• Bachelor's degree in Mechanical, Electrical, Manufacturing, Materials Engineering, or another related technical field, or equivalent relevant experience.
• 5 or more years of relevant experience in Supplier Quality Engineering, Manufacturing Engineering, Supply Chain Engineering, Design Engineering, or a related technical discipline.
• Experience in medical devices, automotive, aerospace, semiconductor, electronics, or another highly regulated or quality-critical manufacturing environment where disciplined process controls, product and process qualification, traceability, and timely issue resolution are required.
• Hands-on experience investigating manufacturing, component, process, or supplier-quality issues and coordinating rapid containment to protect production and customers.
• Practical experience with PPAP, APQP, or comparable product and process qualification methodologies used to establish supplier readiness and production capability.
• Working knowledge of supplier and manufacturing quality tools, including PFMEA/FMEA, Control Plans, SPC, MSA and Gauge R&R, process capability, Cpk/Ppk, First Article Inspection, process validation, root cause analysis, and corrective and preventive action.
• Experience working in fast-moving manufacturing environments where supplier issues may require immediate containment, cross-functional coordination, clear escalation, and timely corrective action.
• Ability to read and interpret engineering drawings, specifications, tolerances, inspection requirements, and technical documentation.
• Experience working directly with suppliers and cross-functional teams to resolve technical, manufacturing, and quality issues.
• Strong organizational and communication skills, with the ability to manage multiple supplier investigations, corrective actions, and improvement activities.
• Willingness to travel to supplier locations domestically and internationally approximately 30-40%, including occasional travel on short notice.
• Ability to work onsite in Palo Alto, California.

What Will Set You Apart

• Direct technical supplier-quality or manufacturing engineering experience in automotive, medical devices, aerospace, semiconductor, electronics, or another industry with rigorous supplier qualification and process-control requirements.
• Experience applying PPAP and APQP in a production environment, including supplier readiness, process qualification, Control Plans, PFMEA, MSA, capability studies, and production-part approval.
• Experience working in an environment where speed of response is critical, including line-down situations, supplier escapes, production interruptions, field issues, or urgent containment activities.
• Ability to balance speed with quality-system discipline, ensuring that immediate containment is followed by evidence-based root cause analysis and sustainable corrective action.
• Experience leading regulatory and technical/for cause supplier audits, process audits, or supplier assessments.
• Experience supporting New Product Introduction, design transfer, supplier selection and qualification, production ramp-up, or product and process changes.
• Knowledge of standards such as ISO 13485, ISO 9001, IATF 16949, VDA 6.3, AS9100, or other relevant industry-specific quality standards.
• Familiarity with Lean Manufacturing, Six Sigma, Design for Manufacturability, and continuous-improvement methodologies.
• Experience analyzing quality and operational data using Excel, Power BI, Minitab, or another statistical or visualization tool.
• Familiarity with electronic Quality Management Systems and ERP systems. SAP experience is preferred.
• Experience with SCARs, non-conforming material processes, Material Review Boards, Qnotes, Supplier Change Notifications, or equivalent quality processes.
• A relevant certification, such as Certified Quality Engineer, Six Sigma Green Belt or Black Belt, or ISO Lead Auditor certification.