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Danaher Corporation Senior Supplier Quality Engineer in Sunnyvale, California

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.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 located in Sunnyvale, CA. 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 assessments, supplier risk classifications, supplier corrective action processes and supplier evaluations.

· Represent and lead Quality in VAVE/engineering projects providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.

· 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.

The essential requirements of the job include:

· Bachelor’s Degree in Engineering, BioMedical/Bioengineering, Life Sciences, Chemistry or related discipline and 5+ years related experience

· Certified Lead Auditor

· 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.

· Experience and mastered the utilization and application of Statistical methods for computing and analyzing data, and driving measures and actions for improvement

· Strong Experience and capability in initiating and driving Manufacturing Process and Quality System improvements working in a Team Environment utilizing best practices and innovation

· Strong Experience and capability in 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 the following:

  • FDA / GMP 21CFR820

  • ISO 13485

  • Certified Quality Engineer

Cepheid, a Danaher 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.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .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. If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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