Senior Supplier Quality Engineer
Cepheid

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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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, Hybrid, with expectation to work onsite three 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:

• Establish needed quality compliance and proactive initiatives including supplier process audits and assessments, supplier risk classifications, supplier corrective action processes, supplier onboarding, and supplier evaluations.

• Define, and apply the manufacturing quality toolset including NCR, SCAR, SRB, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk/PpK, Cp, SPC, incoming inspection plans, inspection methods, DOE, process data analysis, and DMAIC/PSP.

• Initiate and collaborate with product support teams, engineering and others of complex issues on supplier quality issues, supplier changes, supplier quality agreements, and other supplier initiatives. This includes to represent and lead Quality in NPI and Sustaining projects providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and DHF/DMR comply with company policies and governmental regulations.

The essential requirements of the job include:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Biology/Chemistry, or 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 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

• Must be able to travel internationally up to 10%

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

• FDA / GMP 21CFR820

• ISO 13485

• Certified Lead Auditor

• Reagent/Assay and other Material Consumable experience

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

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

The salary range for this role is $103,000 - 154,533. 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 range may be modified in the future.

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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.