Senior Supplier Quality Engineer

Danaher Corporation•Sunnyvale, CA

1d•$116,000 - $159,500•Onsite

About The Position

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 Supplier Quality Engineer will also assist 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 reporting to the Director, Supplier Quality and will be located in Sunnyvale, California with the expectation to work onsite five days per week. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

Requirements

Bachelor’s degree in Mechanical Engineering, Electrical 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 4+ 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
Exposure/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
Instrument Box Level, Injection Molding, and/or other Material Consumables experience

Responsibilities

Execute supplier quality compliance activities including supplier 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