Senior Supplier Quality Engineer

Danaher • Sunnyvale, CA

21h • Onsite

About The Position

At Cepheid, a Danaher operating company, the Senior Supplier Quality Engineer is responsible for quality engineering and management activities with suppliers, driving quality improvement, ensuring compliance, and supporting Value Add Value Engineering (VAVE) / Expansion project activities. The role also assists in maturing Supplier Quality processes and partnering with suppliers to drive proactive and systematic improvements. This position is part of the Supplier Quality Engineering department and will be located in Sunnyvale, CA, with an expectation to work onsite five days per week. The position reports directly to a Senior Manager in Sunnyvale, CA. Cepheid is passionate about improving health care through fast, accurate, molecular diagnostic systems and tests, aiming to be the leading provider of seamlessly connected diagnostic solutions. The company emphasizes making an immediate, measurable impact on a global scale within an environment that fosters career growth and development, driven by a mission to develop groundbreaking solutions for complex health challenges.

Requirements

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Material Science Engineering or similar scientific discipline field with 5+ years of related work experience OR 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.
• Utilization and application of 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 developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry with stringent quality regulations.

Nice To Haves

• FDA / GMP 21CFR820
• ISO 13485 Certified Lead Auditor
• Injection Molding and Electro-Mechanical Systems
• 10% domestic/international travel may be required.

Responsibilities

• 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 including NCR, SCAR, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification and 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

Benefits

• broad array of comprehensive, competitive benefit programs that add value to our lives
• health care program
• paid time off
• medical/dental/vision insurance
• 401(k)
• bonus/incentive pay

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees