Quality Assurance Specialist II

2 months ago

Lodi, United States Cepheid Full time

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 Quality Systems Specialist is responsible for reviewing records to comply with QSR and ISO requirements.
They make recommendations for improvement and create training materials and operating manuals. This person is involved with various quality continuous improvement activities.

This position is part of the Quality Systems Specialist II and will be located in Lodi, CA

In this role, you will have the opportunity to:

Collaborate with the manufacturing department for scheduling line clearance and line setup activities. Review records, documents, and eDMS electronic documentation for completeness and compliance with QSR and ISO requirements.

Generate standard operating procedures to define and improve quality system functions.

Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports. Lead and participate in interdepartmental initiatives for continuous improvement.

The essential requirements of the job include:

High school diploma 2 years of relevant experience in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience.

Must be familiar 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:

Experience in DNA diagnostics or other medical devices.

This position requires a 12-hour shift (6 pm - 6 am) with an alternating 3-day/4-day work schedule.

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.

The salary range OR the hourly range for this role is $25.38 - $35.88 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 is only applicable for jobs to be performed in Colorado. 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.

#LI-GC1

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.

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.

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