Quality Systems Supervisor - Second Shift

Company: Cepheid
Location: Isleton
Posted on: November 24, 2022

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 Supervisor, Quality Systems is responsible for maintaining the Quality System shared services including CAPA, Internal and External Audit and Document Control at Cepheid. This position is accountable for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities. This position is part of the Quality Organization and will be located in Lodi, California. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions. In this role, you will have the opportunity to:

• Responsible for the Change Control release of all Change Orders for the organization. Provide guidance on GMP guidance and educate reports on best practices
• Supervises direct report(s) to ensure all Quality System Shared Service functions are reviewed and that changes are properly documented and structured.
• Ensure management and maintenance of all Quality System elements to meet company's
  business needs, developing company best practices, standards, and continuous improvement.
• Establishes and maintains policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) as well as all other applicable global regulatory requirements.
• Build and develop a high performing quality team. Ensures harmonization of the global
  Quality Systems and processes between all sites and collaborates across the organization at all levels. The essential requirements of the job include:
  • High School degree with 8+ years of experience OR Bachelor's degree with 5+ years of experience OR Master's degree with 3+ years of experience
  • > 3 years of people management Experience
  • Knowledge of domestic and international quality systems
  • Knowledge of ISO 13485
  • Experience with critical parts of internal audits
  • Knowledge of CAPAs and involvement with deviations It would be a plus if you also possess previous experience in:
    • High School degree with 8+ years of experience OR Bachelor's degree with 5+ years of experience OR Master's degree with 3+ years of experience
    • > 3 years of people management Experience
    • Knowledge of other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulation 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. Check out our benefits at danaherbenefitsinfo.com. The essential requirements of the job include:
      • High School degree with 8+ years of experience OR Bachelor's degree with 5+ years of experience OR Master's degree with 3+ years of experience
      • > 3 years of people management Experience
      • Knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulation
        - When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization. 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. Please contact us at applyassistance@danaher.com to request accommodation.
        
        If you've ever wondered what's within you, there's no better time to find out.

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