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Danaher Corporation Quality / Compliance Specialist I in Lodi, California

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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Quality Systems Compliance Specialist is responsible for supporting the quality system processes including QMS process (Deviations, Non-Conformances, CAPA) as well other department functions such as Gemba audit as needed.

This position is part of the Cepheid Quality Systems and will be located onsite 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:

  • As a liaison for Quality, provide guidance to cross-functional teams on non conformance activities and Planned Deviation Report.

  • Support Management with tracking and trending any QMS related issues

  • Review records and documents, for completeness and compliance with QSR and ISO requirements.

  • Support in internal audits to ensure implemented process improvements and systems are successful and compliance

The essential requirements of the job include:

  • Bachelor's of Science preferred. Equivalent experience may be considered.

  • 2+ years of experience in quality (Medical Device preferred but not required)

  • Ability to interact professionally and efficiently with various functional department and with all levels of employees and management.

  • Computer skills, e.g. word, excel, access, Microsoft project, electronic documentation systems, ERP systems.

  • Maintains a positive attitude, is self- motivated and works well independently and as part of a team.

  • Must be willing and able to adjust work schedule depending on business needs

    Preferred Requirements:

  • Knowledge of ISO 13485-2016 standards and FDA/QSR standard

Cepheid, a Danaher operating 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.

The salary range for this role is $59,500 - $81,800. 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. We may ultimately pay more or less than the posted range. 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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At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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 (https://www.dol.gov/agencies/ofccp/posters) .

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.

Operating Company: Cepheid

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