Senior Supplier Quality Engineer

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

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.

In this role, you will have the opportunity to:

* 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

The essential requirements of the job include:

* 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

Travel, Motor Vehicle Record & Physical/Environment Requirements:

* 10% domestic/international travel may be required

It would be a plus if you also possess previous experience in:

* FDA / GMP 21

CFR
820 / ISO 13485

* Certified Lead Auditor

* Instrument Box Level, Injection Molding, and/or other Material Consumables experience

Cepheid, a Danaher operating company, offers a broad array…