Senior Quality Systems Specialist

Danaher • Sunnyvale, CA

13d • Onsite

About The Position

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 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

Requirements

• 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 d octoral 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
• Excellent verbal and written communication skills
• Ability to travel domestically and internationally up to 15% annually
• Day t ravel to Fremont, Lodi, and Newark, California
• O vernight travel to Lodi, California and other domestic and international locations as necessary depending on business need

Nice To Haves

• ASQ Certified Quality Auditor (CQA) Certification
• ISO 9001:2015 process and assessment certification activities
• Regulatory Intelligence program
• Technical Writing

Responsibilities

• 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

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees