Danaher Corporation - Quality Systems Specialist - Diagnostics (6pm - 6am) in Lodi, CaliforniaAt 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.The Quality Systems Specialist is responsible for reviewing records to comply with QSR and ISO requirements.
This person will make recommendations for improvement and create training materials and operating manuals.
This person will be involved with various quality continuous improvement activities.This position is part of the Quality Assurance Team and will be located in Lodi, CA.
The schedule is Night shift 6pm - 6am (Shift C or D, some weekends may be required).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 the release of raw materials, work in progress, and final products, including reagents, components, and instrumentation-related products.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:Experience in DNA diagnostics or other medical devices.At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.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.This job is also eligible for bonus/incentive pay.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.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 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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