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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll 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 worlds 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 and will be located in Sunnyvale CA with expectation to work onsite five days per week. The position will report directly to Senior Manager in Sunnyvale CA. 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 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

The essential requirements of the job include:

• Bachelors degree in Mechanical Engineering Industrial Engineering Biomedical Engineering Material Science Engineering or similar scientific discipline field with 5 years of related work experience OR Masters 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.

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

• FDA / GMP 21CFR820
• ISO 13485
• Certified Lead Auditor
• Injection Molding and Electro-Mechanical Systems

10% domestic/international travel may be required.

Cepheid a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at .

The salary range for this role is $116000 - 159500. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .