Sr. Quality Specialist

Cepheid Inc; Sunnyvale (CA); On-site; USD 111,000 - 153,000; Full time

Job summary

Cepheid Inc is seeking a Sr. Quality Specialist to support quality systems related to assay development in Sunnyvale, California. The role requires a strong educational background in scientific disciplines and hands-on experience in the medical device industry. Ideal candidates will engage in critical quality management activities while collaborating across teams to ensure compliance with FDA and ISO regulations.

Benefits

Comprehensive benefits package

Paid time off

401(k) plan

Medical/Dental/Vision insurance

Qualifications

• 5+ years of experience in Quality or 3+ years with an M.S. degree.
• Experience in FDA QSR and ISO 13485 regulations.
• Ability to perform risk-based recommendations and technical oversight.

Responsibilities

• Participate in product development teams for quality system guidance.
• Ensure documentation is ready before product launches.
• Design and run stability studies to establish shelf-life.

Skills

Quality Systems

Risk Management

Statistical Analysis

Assay Development

Education

B.S. degree in Chemistry, Biology, or related field

M.S. degree in Chemistry, Biology, or related field

Tools

Microsoft Word

Microsoft Excel

Minitab

Microsoft Visio

Microsoft PowerPoint

Job description

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.

The essential requirements of the job include:

• 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.

It would be a plus if you also possess previous experience in:

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

The salary range for this role is $111,100-$152,800. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

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

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [e-mail] to request accommodation.