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    Food Quality Assurance Manager - Lodi, CA, United States - Cepheid

    Cepheid
    Cepheid Lodi, CA, United States

    2 weeks ago

    Default job background
    Full time
    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.

    At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

    The Quality Assurance Supervisor leads the team responsible for the maintenance of Quality System documentation as related to Device History Record (DHR) compliance and ensuring accuracy and traceability of data and in accordance with the requirements of FDA's Quality System Regulation (QSR) and ISO 13485(ISO).

    This position is part of the Quality Assurance Team and will be located in Lodi, California.

    Prioritize the daily QA team activities to ensure DHR review and product release service levels are met.
    Train and supervise QA personnel to support QA review and release activities.

    Address deficiencies and ensure completion of follow-up actions, specifically those that target process fixes to maintain consistent resolution to all batch review issues.

    Generate or update written standard operating procedures to define and improve Quality System functions.
    Develop and maintain QA metrics to track batch record and document review capabilities and workflow. Maintain and report out Daily Management KPI and release metrics.

    High School degree with 8+ years of leadership experience, Bachelor's degree with 5+ years of experience in scientific, quality system, or related discipline, with minimum 3 years of quality related experience in a regulated manufacturing environment or Medical Device experience

    Significant experience and understanding of quality assurance processes within the medical device industry with an analytical and organized approach.

    We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

    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 value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.

    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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