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Senior Quality Engineer

Company: Danaher
Location: Sunnyvale
Posted on: November 18, 2021

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.

As a Senior Quality Engineer, you will support multi-functional teams by providing design verification of a modified bioreactor system's user requirements, functional specifications and product accompanying documentation. You will select and/or develop test requirements and protocols for the modified products, and you will be trusted with independently guiding and executing test activities to ensure product quality and regulatory compliance.

This position is part of our Quality team and is located in Sunnyvale, CA.

In this role, you will have the opportunity to:

* Assure project alignment to Design Controls to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.


* Support and drive countermeasures in instances when deviations to the project plan occur.


* Typically serves as a project or team leader for a complex business concept or application.


* Support project core teams throughout the phase gate process for new product development and ensure compliance to Cepheid and Danaher policies and procedures.


* To identify, analyze, tackle problems and drive decisions.



The essential requirements of the job include:

* 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.


* Strong background and experience in NPI Quality for instrumentation hardware and qualification.


* Consistent track record with system and or reagent product development


* Experience in the application of production and process controls including process validation, control plans and statistical process control.


* Highly developed experience with risk management and design control principles.



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

* Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820 is strongly desirable.


* Knowledge and understanding of CPK process value


* A quality engineering certification to include CQE, CRE, CQA, etc. from the American Society for Quality (ASQ), or other qualifying organizations.


* Experience in injection plastic molding processes


* Certified in Lean Manufacturing and/or Six Sigma


* Experience in product mechanical evaluation, testing and GD&T



Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

If you've ever wondered what's within you, there's no better time to find out.

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

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 applyassistance@danaher.com to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.

Keywords: Danaher, Sunnyvale , Senior Quality Engineer, Engineering , Sunnyvale, California

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