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 Quality Systems Specialist III is responsible for functioning as Lead Internal Auditor to schedule, plan, perform, and document internal audits of Cepheid’s Quality Management System (QMS), providing continuous and rigorous assessment to identify and implement improvements.

This position reports to the Senior Manager Quality Systems - Compliance and is part of the Quality Systems department located in Sunnyvale, CA and will be an on-site role.  

In this role, you will have the opportunity to:

Function as Lead Auditor to schedule, plan, perform, and document internal audits to provide continuous and rigorous assessment of the Cepheid QMS to identify areas of strengths and nonconformances, and collaborate with nonconformance owners to ensure all findings are closed in a timely manner with effective corrective actionsSupport external audit management (e.g., FDA, ISO, corporate, foreign governments, etc.,) including pre-audit, during audit, and post-audit follow-up activitiesMaintain up-to-date knowledge and ensure compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities 

The essential requirements of the job include:

Bachelor’s degree in field with 2+ years of related work experience or master’s degree with 1+ years of related work experiencePossess up to date knowledge or domestic and international quality systems standards and regulations including, but not limited to, 21 CFR Part 820, ISO 13485, MDSAP country related requirements (TGA, ANVISA RDC 665, CMDR, MHLW MO 169), IVDD, IVDR, NMPA, TAIWAN-MEDDEV-QMS

Travel, Motor Vehicle Record & Physical/Environment Requirements:

Ability to travel domestically and internationally up to 10% annually; day travel to Fremont, Lodi, and Newark, California required. Overnight travel to Lodi, California and other domestic and international locations as necessary depending on business need.

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

ISO 9001:2015Regulatory Intelligence

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 Danaher Benefits Info.

The annual salary range for this role is $84,100 - $115,800. 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.

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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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

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.

The U.S. EEO posters are available here.

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:1-202-419-7762 or applyassistance@danaher.com.