Cepheid · 2 days ago
Senior Quality Systems Specialist
Sunnyvale, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $130K/yr
5+ years expCepheid is dedicated to enhancing health care through innovative diagnostic testing solutions. The Senior Quality Systems Specialist will lead internal audits of Cepheid’s Quality Management System, ensuring compliance with regulations and implementing improvements. This role involves collaboration across various levels of the organization and participation in external audits.
BiotechnologyGeneticsHealth CareHealth DiagnosticsMedical
Hiring Manager
Lucille Crawford-Sarkodie, MBA-HRM
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
Cepheid
Cepheid is a diagnostics company that provides molecular systems and tests for organisms and genetic-based diseases.
5001-10000 employees
H1B Sponsorship
Cepheid 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (92)
2024 (103)
2023 (83)
2022 (137)
2021 (96)
2020 (43)
Funding
Current Stage
Public CompanyTotal Funding
$117.85MKey Investors
Biomedical Advanced Research and Development Authority (BARDA)Wheatley PartnersInnogenetics
2021-10-22Grant· $63.8M
2021-07-29Grant· $27M
2016-09-06Acquired
Leadership Team
John L. Bishop
Chairman & CEO
Kerry Flom
Executive Vice President; Chief Regulatory Officer
Recent News
2025-11-08
Company data provided by crunchbase