Cepheid · 14 hours ago
Sr. Quality Specialist
Sunnyvale, CA
Full-time
Onsite
Mid, Senior Level
$111K/yr - $153K/yr
5+ years expCepheid is dedicated to improving health care through fast, accurate diagnostic testing. The Sr. Quality Specialist will support quality systems activities related to assay development and ensure compliance with FDA and ISO regulations.
BiotechnologyGeneticsHealth CareHealth DiagnosticsMedical
Responsibilities
Participate as Quality representative on product development teams which includes providing guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Assessments, and Design Reviews; and provide guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable US FDA, EU IVDR, and other applicable global standards
Fulfill all quality planning, stability, and risk management deliverables with feedback from cross-functional teams
Ensure required documentation is completed prior to the new product launch, and coach product development teams to successful completion where necessary
Provide guidance and technical oversight of product shelf-life/stability program. Design and execute product stability studies, using proper statistical tools to perform data analysis, generate technical reports and establish product shelf-life
Provide technical expertise for post market investigations and design changes, including documentation of investigations following standard out of specification SOPs and assessment of changes using design control methods
Qualification
Required
B.S. degree with 5+ years of related experience or M.S. degree with 3+ years of related experience, degree in Chemistry, Biology, or related physical or biological science field
Related work experience in Quality with a focus on assay development in a medical device or IVD industry with applicable knowledge of FDA QSR, EU IVDR and other global regulations ISO 13485 and ISO 14971
Experience in implementing design control and risk management activities
Experience with technical data and capable of making risk-based recommendations, taking into account broad perspectives that support both the regulations and the business
Adept with Microsoft Word, Excel, Visio, PowerPoint, and Minitab
Preferred
Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR
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