Danaher Corporation · 2 days ago
Senior Quality Systems Specialist
Sunnyvale, California, United States
Full-time
Onsite
Mid, Senior Level
$100K/yr - $130K/yr
3+ years expCepheid, a Danaher Corporation company, is dedicated to improving healthcare through innovative diagnostic testing solutions. The Senior Quality Systems Specialist will lead internal audits of the Quality Management System, ensuring compliance with regulatory standards and driving continuous improvement across the organization.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
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
Qualification
Required
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
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
Preferred
ASQ Certified Quality Auditor (CQA) Certification
ISO 9001:2015 process and assessment certification activities
Regulatory Intelligence program
Technical Writing
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Danaher Corporation
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
10001+ employees
H1B Sponsorship
Danaher Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (3)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown1979-01-05IPO
Leadership Team
Rainer Blair
President & CEO
Thomas Joyce
President & CEO
Recent News
mass-spec-capital.com
2026-01-09
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2026-01-05
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