Quality Systems Specialist II
Posted on: 4 Sep 2021
Lodi, CA
Job Description
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 II is responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485 (ISO). Specifically, functions including record review, product release and document control fall under this position.
This position is part of the Quality Assurance team and will be located in Lodi, California.
In this role, you will have the opportunity to:
Review records and documents, for completeness and compliance with QSR and ISO requirements.
Review Device History Records (DHR) to support release of raw materials, work in progress and final products.
Collaborate with other function teams to resolve batch record discrepancies or errors as it related to Good Documentation Practice.
Assist to improve standard operating procedures and 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, as needed.
The essential requirements of the job include:
High School degree (or equivalent experience) with 4-6 years of related work experience OR
AA or Technical Degree with 2-4 years of related work experience
Computer skills: Microsoft Office: Word, Excel, PowerPoint.
Danaher
Washington, DC
Danaher Corporation designs, manufactures, and markets professional, medical, industrial, and commercial products and services worldwide. The company’s Life Sciences segment provides mass spectrometers; cellular analysis, lab automation, and centrifugation instruments; microscopes; and genomics consumables. This segment also offers filtration, separation, and purification technologies to the biopharmaceutical, food and beverage, medical, aerospace, microelectronics, and general industrial sectors. Its Diagnostics segment provides chemistry, immunoassay, microbiology, and automation systems, as well as hematology and molecular diagnostics products. This segment offers analytical instruments, reagents, consumables, software, and services for hospitals, physicians’ offices, reference laboratories, and other critical care settings.
The company’s Dental segment provides consumables, equipment, and services to diagnose, treat, and prevent disease and ailments of the teeth, gums, and supporting bone. This segment offers implant systems, dental prosthetics, and associated treatment planning software; orthodontic bracket systems and lab products; endodontic systems and related consumables; restorative materials and instruments; infection prevention products; digital imaging systems and software; air and electric powered handpieces, and consumables; and treatment units.
Its Environmental & Applied Solutions segment offers instrumentation, services, and disinfection systems to analyze, treat, and manage water in residential, commercial, industrial, and natural resource applications. This segment also provides analytical instruments, software, services, and consumables for consumer, pharmaceutical, and industrial products. The company was formerly known as Diversified Mortgage Investors, Inc. and changed its name to Danaher Corporation in 1984. Danaher Corporation was founded in 1969 and is headquartered in Washington, the District of Columbia.
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IndustryManufacturing
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No. of Employees71, 000
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Website
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Jobs Posted2348
