Quality Assurance Specialist II

3 weeks ago

Lodi, California, United States Cepheid Full time

At Cepheid, we are passionate about improving healthcare through fast, accurate diagnostic testing. Our mission drives us to develop scalable, groundbreaking solutions to solve the world's most complex health challenges. As a Quality Assurance Specialist II, you will be responsible for reviewing records to comply with QSR and ISO requirements, making recommendations for improvement, and creating training materials and operating manuals. This role is part of the Quality Systems Specialist II and will be located in Lodi, CA.

Key Responsibilities:

  • 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.

Requirements:

  • High school diploma (or equivalent experience) with 2-4 years of relevant experience in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience.
  • AA or Technical Trade Degree with 1-2 years of work experience.
  • Must be familiar with ISO standards and applicable regulatory requirements (CE/FDA/QSR) and GDP.

Preferred Qualifications:

  • Experience in DNA diagnostics or other medical devices.
  • Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a healthcare 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 $25.38 - $33.65. 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 a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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.

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