Quality Systems Specialist I
Cepheid

Job Info

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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.

This position is part of the Quality Assurance Department and will be located in Lodi, CA. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Review records and documents, for completeness and compliance with QSR and ISO requirements.
• Review batch records to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products to ensure they are on the right path.
• Generate standard operating procedures to define and improve quality system functions

The essential requirements of the job include:

• High school diploma with at least 2 years of work experience in a manufacturing environment.
• Familiarity with ISO standards and applicable regulatory requirements (CE/FDA/QSR) and GDP
• Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.

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

• DNA diagnostics or other medical devices.

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.

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.

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