Senior Quality Operations Engineer

Company: Cepheid
Location: Lodi
Posted on: November 22, 2021

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, a patient is waiting.Learn about the , which makes everything possible.The Senior Quality Operations Engineer is responsible for supporting manufacturing, contract manufacturing, and complaint handling. Coaching and develop extended Quality team members as necessary to assure a common understanding of the product development process, project goals, and growth opportunities within the Quality Organization.This position is part of the Quality Engineering Department and will be located in Lodi, California. In Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.In this role, you will have the opportunity to:

• Support project core teams throughout the phase-gate process for new product development and ensure compliance with Cepheid and Danaher policies and procedures.
• Establish and monitor the use of risk assessment tools for project tracking and management.
• Provide support to process validation and other processes on the manufacturing floor, warehouse, and facilities as required.
• Drive improvements in process capability and quality of products.
• Regularly monitor, investigate and review nonconformance activities and generate CAPAs/SCARs based on trends/issues identified from operations, MRB and drive them to closure.The essential requirements of the job include:
  • Bachelor s degree in field with 5+ years of related work experience OR Master s degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience
  • Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485.It would be a plus if you also possess previous experience in:
    • Experience in product mechanical evaluation & testing and GD&T.
    • Certified Quality Engineer from the American Society for Quality (ASQ) or other qualifying organizations. Examples include the CQE, CRE, CQA, etc.Cepheid, 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-LH2 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 tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID 19 as a condition of employment, subject to reasonable accommodation as required by law.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: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain

Keywords: Cepheid, Lodi , Senior Quality Operations Engineer, Professions , Lodi, California