Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

Responsible for quality engineering and management activities with suppliers, driving quality improvement, ensuring compliance, and supporting Value Add Value Engineering (VAVE) / Expansion project activities. Also assists in maturing Supplier Quality processes and partners with suppliers to drive proactive and systematic improvements.

Sunnyvale, CA – onsite, five days per week. Reports directly to Senior Manager, Sunnyvale, CA.

• Execute supplier quality compliance activities including supplier process audits, supplier assessments, supplier risk classifications, supplier corrective action processes (SCAR), supplier onboarding, and supplier evaluations.
• Apply manufacturing quality engineering toolsets such as NCR, SCAR, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification, validation plans, validation protocol development, Cpk/PpK, SPC, DOE, incoming inspection plans, inspection methods, process data analysis, and DMAIC.
• Manage supplier quality issues, supplier changes, supplier quality agreements, and supplier-driven initiatives across assigned product lines.
• Lead Quality Engineering deliverables for NPI and sustaining projects, ensuring DHF and DMR compliance with company procedures and regulatory requirements.
• Provide engineering analyses and quality oversight to ensure product and process compliance with applicable manufacturing, validation, and regulatory standards.

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Material Science Engineering, or similar scientific discipline with 5+ years of related work experience, or a Master’s degree with 3+ years of related work experience.
• Develop and understand the application of production and process controls, including process validation, process control plans, and statistical process control utilizing best practice and innovation.
• Utilize and apply statistical methods for computing and analyzing data and driving measures and actions for improvement.
• Background in New Product Introduction, manufacturing process, and quality system improvements working in a team environment utilizing best practices and innovation.
• History of developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry with stringent quality regulations.

• FDA/GMP 21
  
  CFR
  820 experience.
• ISO 13485 experience.
• Certified Lead Auditor.
• Injection molding and electro‑mechanical systems experience.

10% domestic/international travel may be required.

Salary range: $116,000 – $159,500. This role is also eligible for bonus/incentive pay. Benefits include paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. Cepheid offers a comprehensive benefits program that adds value to our lives. Benefits information is available at

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