Supplier Quality Engineer

Regulatory Jobs; Palo Alto (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Varian Medical Systems, a Siemens Healthineers company, seeks a hands-on Supplier Quality Engineer to join onsite in Palo Alto, CA. You will drive supplier quality, containment, audits, and cross-functional resolutions across the product lifecycle.

Role requires 5+ years in supplier quality or related fields in regulated manufacturing, plus hands-on problem solving (8D/5 Whys/Ishikawa) and PPAP/APQP experience. Onsite work in Palo Alto is required.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Manufacturing, Materials Engineering, or related field.
• 5+ years of experience in Supplier Quality Engineering, Manufacturing Engineering, or related discipline.
• Experience in regulated environments (medical devices, automotive, aerospace, or semiconductor).
• Hands-on experience investigating issues and coordinating rapid containment.
• Experience with PPAP/APQP and qualification methodologies.
• Knowledge of PFMEA, Control Plans, SPC, MSA, Gage R&R, process validation.

Responsibilities

• Manage supplier quality for an assigned group of suppliers and be main contact for supplier quality matters.
• Monitor performance using dashboards and KPIs; communicate risks and priorities.
• Investigate supplier issues affecting incoming inspection, manufacturing, and field service.
• Lead root cause investigations (8D, 5 Whys, Ishikawa) and corrective actions.
• Review CAPAs to ensure root causes and recurrence prevention.
• Support supplier readiness through PPAP/APQP and audits.
• Coordinate with cross-functional teams on supplier changes and qualification.

Skills

Supplier Quality

Root Cause

Cross-functional

8D/5 Whys

FMEA

MSA

SPC

Quality Tools

Education

Bachelor's degree

Tools

PFMEA

APQP

PPAP

Gauge R&R

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Varian Medical Systems, a Siemens Healthineers company, is seeking a motivated and hands‑on Supplier Quality Engineer to join our team onsite in Palo Alto, California.

In this role, you will work directly with suppliers and cross‑functional teams to improve component quality, resolve technical and manufacturing issues at the supplier locations, and strengthen supplier processes. You will support quality across the complete product lifecycle, from new product introduction and incoming inspection through manufacturing, installation, and field service.

We welcome candidates from medical devices, automotive, aerospace, semiconductor, electronics, and other highly regulated or quality‑critical manufacturing industries. The ideal candidate has demonstrated hands‑on technical experience and has worked in an environment where rigorous quality standards, PPAP or equivalent product and process qualification methods, and rapid response to supplier and production issues are essential.

This is an excellent opportunity for an engineer who combines structured quality discipline with the ability to act quickly, work directly with suppliers, and drive issues through effective resolution.

This role is designed to be completed onsite in Palo Alto, California

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