Sr. Quality Specialist

Danaher•Sunnyvale, CA

2d•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 Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, specially design control and risk management activities in accordance with FDA and ISO regulations. This position is also responsible to apply scientific knowledge to plan, design, development, test, analyze testing data and document stability studies to establish the product shelf-life. This position is part of the Product Life Cycle Quality & Stability team. It will be in Sunnyvale, California as an Onsite position. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions. In this role, you will have the opportunity to: 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.

Requirements

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 l 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

Nice To Haves

Quality Systems/Quality Engineering background in molecular biology products or molecular diagnostic products utilizing PCR

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
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