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 Quality Systems Specialist 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 will work with the Senior Manager Quality Systems Compliance.
This position is part of the Quality department and will be located 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:Function as Lead Auditor to schedule, plan, perform, and document internal audits to provide continuous and rigorous assessment of the Cepheid QMS to identify and implement improvements and ensuring that all internal audit findings are closed in a timely manner with effective corrective action.
Participate in external audit management (e.g. FDA, ISO, Danaher Corporate, foreign governments), in either a supporting or lead role, related to pre-audit, during audit, and post-audit activities including follow-up.
Maintain 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
Provide cross-functional compliance support for global QMS and Intracompany Quality Agreement requirements. Function as SME for compliance related topics, including the assessment of the overall impact to Cepheid’s QMS of the proposed changes or issue.
Collaborate across the organization at all levels, across functional groups and geographic locations, including executive management
The essential requirements of the job include:
Bachelor’s degree in field with 5+ years of related work experience or master’s degree in field with 3+ years of related work experience or doctoral degree in field with 0-2+ years of related work experience.
Possess significant knowledge of 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 15% annually; scheduled day travel to Fremont, Lodi, and Newark, California required as necessary. 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:
ASQ Certified Quality Auditor (CQA) Certification
ISO 9001:2015 process and assessment certification activities
Regulatory Intelligence program
Technical Writing
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.
The salary range for this role is $100,000 – $150,000. 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 range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer a 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 [email protected].
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What We Do
Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.
