Sr. Quality Specialist

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

Job summary

Cepheid is seeking a Sr. Quality Specialist in Sunnyvale, CA, to support assay development and ensure compliance with FDA and ISO regulations. The role involves critical activities in quality systems, risk management, and documentation, offering opportunities for significant contributions and career growth.

Benefits

Comprehensive benefits package

Paid time off

Medical/dental/vision insurance

401(k) plan

Qualifications

• B.S. degree with 5+ years or M.S. degree with 3+ years in relevant field.
• Experience in medical device or IVD industry focusing on quality.
• Familiarity with FDA QSR and global regulations ISO 13485 and ISO 14971.

Responsibilities

• Participate as a Quality representative on product development teams.
• Fulfill quality planning, stability, and risk management deliverables.
• Provide guidance and technical oversight on product stability programs.

Skills

Assay development

Quality compliance

Risk management

Education

B.S. or M.S. degree in Chemistry, Biology, or related science

Tools

Microsoft Word

Microsoft Excel

Minitab

Microsoft Visio

Microsoft PowerPoint

Job description

Join to apply for the Sr. Quality Specialist role at Cepheid

Join to apply for the Sr. Quality Specialist role at Cepheid

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.

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.

The EEO posters are available here.

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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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