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Director, Manufacturing Quality

Company: Cepheid
Location: Lodi
Posted on: January 4, 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 which makes everything possible.The Director, Manufacturing Quality is responsible for providing management and overall strategic direction and operational coordination of activities for the Manufacturing Quality Operations Quality Engineering teams. The Director, Manufacturing Quality will ensure compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements and alignment with company objectives and Quality Standards. The Director, Manufacturing Quality will report directly to the Senior Director, Manufacturing Quality (Site Quality Leader) and will supervise the Lodi, CA Quality Control and Quality Assurance functions.This position is part of the Quality Operations and will be located in Lodi California.In this role, you will have the opportunity to:

  • Build, develop and manage a high performing Manufacturing Quality Operations Quality Engineering team
  • Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management
  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
  • Lead the Manufacturing Quality Engineering team to ensure Cepheid s quality standards are consistently achieved and maintained. Ensure that processes are sufficiently capable to deliver and maintain standards, and develop action plans using multi-functional teams to address weaknesses or deficiencies. Develop and implement policies and ensuring standards are detailed, robust, communicated and measured consistently throughout internal manufacturing sites and external suppliers
  • Critically analyze, using appropriate sources of data, Cepheid s operations capabilities; setting strategy, structure, and processes to drive sustained quality improvement in local manufacturing facility while efficiently deploying our Danaher Business System (DBS) tools and concepts to maximize process efficiency and effectiveness
  • Develop best-in-class, common systems for completely integrating Quality Management Systems with Operational processes and the Cepheid s Operating System. Develop performance indicators and scorecards to measure quality level performance within the manufacturing facility.
  • Align site and quality objectives with the Business Plan, Operations Objectives, and the Global Manufacturing Quality System to assure effective and efficient use of resources and manufacturing quality completion and set facility operations goals to improve processes.
  • Collaborate with NPI teams to ensure that quality attributes, manufacturability and lessons learned from existing products (e.g. production performance, quality problems, complaints) are integrated into the design and manufacturing processes.
  • Ensure compliance of company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
  • Lead employee development, communication and training programs in connection with the company's strategic goals, quality objectives, and operational systemsThe essential requirements of the job include:
    • Bachelor's Degree in Engineering, Biology, Biochemistry, or related field with 14 years of related experience and at least 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
    • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
    • Track record of measurable, operational improvements to Quality Systems related functions.
    • DBS, LEAN or Six Sigma operational excellence training or certificationIt would be a plus if you also possess previous experience in:
      • Seven years of Department Leadership experience in managing both processes and resources.
      • Training and certificates in quality or regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
      • Experience in Manufacturing Operations preferably in molecular diagnosticsCepheid, a Danaher 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 .When you join us, you ll also be joining Danaher s global organization, where 69,000 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 is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we ll empower you to push the boundaries of what s possible.If you ve ever wondered what s within you, there s no better time to find out.#LI-SS2#LodiWhen you join us, you ll also be joining Danaher s global organization, where 69,000 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 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 .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.If you ve ever wondered what s within you, there s no better time to find out. Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

Keywords: Cepheid, Lodi , Director, Manufacturing Quality, Executive , Lodi, California

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