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DIRECTOR, QUALITY SYSTEMS

Company: Cepheid
Location: San Leandro
Posted on: June 10, 2024

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 which makes everything possible.The Director, Quality Systems is responsible for providing management and overall strategic direction and operational coordination of activities for site Quality Operations and Regulatory Compliance and ensuring compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements and alignment with company objectives and Quality Standards.This position will report directly to the Vice President, Manufacturing Quality and will manage the Newark, CA and Sunnyvale, CA Manufacturing Quality organization encompassing Quality Control, Quality Engineering, Quality Assurance, Quality Systems and Calibration functions. This position will also oversee Quality related matters at the Fremont Distribution Centre (EBLC).This position is part of the Manufacturing Quality Organization and will be in Sunnyvale, CA. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.In this role, you will have the opportunity to:

  • Develop and manage a high performing Quality team including Quality Control, Quality Engineering, Quality Assurance, Quality Systems and Calibration functions.
  • Direct and oversee the quality planning processes; and develop resourcing strategies, allocate budgets, staff, tools, and specialized support necessary for efficient operations.
  • Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment.
  • Maintain the CAPA and NCR systems, Calibration Program, Document Control and Lead site Change Management and Risk Management activities.
  • Collaborate across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.
  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
  • Lead employee development, communication, and training programs in connection with the company's strategic goals, quality objectives, and operational systems.The essential requirements of the job include:
    • Bachelor's Degree in Engineering, Biology, Biochemistry, or related field with 14 years of related experience OR Master's degree in field with 12+ years of related work experience
    • 3 plus years hands-on experience in Biotechnology and Quality Control, or Molecular Biology/PCR assays.
    • 4 years of Supervisory or Department Lead experience in managing both processes and resources
    • Medical Device industry experience, preferably IVD with expert knowledge of US FDA and ISO requirements for Quality Systems
    • Strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity.
    • Detail-oriented with strong organizational skills and high-quality standards; able to manage and lead the organization effectively through changing conditions, processes, approaches and audits.
    • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals, with a track record of measurable, operational improvements to Quality Systems related functions.It would be a plus if you also possess previous experience in:
      • Seven years of Department Leadership experience in managing both processes and resources; preferably in Molecular Diagnostics.
      • DBS, LEAN or Six Sigma operational excellence training or certification.
      • Experience in Manufacturing Operations, managing both Direct and Indirect labor.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.The salary range for this role is $165,400-235,600. 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.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .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 .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 to request accommodation.

Keywords: Cepheid, San Leandro , DIRECTOR, QUALITY SYSTEMS, Executive , San Leandro, California

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