Quality Assurance Engineer
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.

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The Quality Assurance Engineer is responsible for ensuring product quality of enzyme, chemical and oligonucleotide reagent products, supporting facilities and equipment qualification, and strengthening compliance to FDA's Quality System Regulation and ISO 13485 Standard. This position will make significant impact to the Bothell site by supporting facility growth and reagent products sustainment.

This position is part of the Quality department and will be located in the Cepheid Bothell, Washington facility. Be part of the team that ensures the quality of every product, providing accurate diagnosis to every patient.

In this role, you will have the opportunity to:

• Qualify equipment, utilities and facilities, validate production processes and test methods. This includes developing, advising, writing, or reviewing protocols, providing guidance during protocol execution, deviation investigations, test result analysis and final reports.

• Represent Quality by collaborating with product or facility project teams, driving risk management, and focusing on controls, process transfer, validation, data analysis, monitoring, and continuous improvement.

• Support Quality System processes to ensure compliance to the Cepheid Quality Management System by identifying compliance gaps, writing or revising procedures, and implementing processes to improve efficiency while ensuring compliance.

The essential requirements of the job include:

• Bachelor's degree in Chemical Engineering or in a Chemistry / Life Science discipline

• Ability to work in laboratory environments.

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

• Experience in an FDA regulated industry or ISO certified organization, for example: FDA's 21 CFR 820 regulation or ISO 13485:2016 standard.

• Experience with chemistry production (especially oligonucleotide chemistry).

• Knowledge about risk analysis, qualification and validation of products and processes.

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.

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When you join us, you'll also be joining Danaher's global organization, where 80,000 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.

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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 applyassistance@danaher.com to request accommodation.

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