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Quality Engineer, Sr - 2nd Shift

Company: Cepheid
Location: Lodi
Posted on: January 11, 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 2nd shift Sr. Quality Operations Engineer is responsible for actively influencing the technical application of quality systems management within manufacturing to assure compliance with corporate policies, 21CFR820, ISO 13485, the Medical Device Directive, and other applicable regulatory agencies. Quality Operations Engineering is a growing team within the Quality Organization and has become instrumental in driving continuous improvement to assure product consistency and reliability for sustaining operations.This position is part of the Lodi Quality Organization and will be located Lodi, CA. Quality Operations Engineering s vision is to synchronize risk-based quality centric decision making with Cepheid s A Better Way to assure products are manufactured as intended.In this role, you will have the opportunity to:

  • As a liaison for Quality, provide guidance to cross-functional teams for problem solving, nonconformity process, risk mitigation, and change control that conform to established requirements
  • Develop, track, and monitor project adherence to Design Controls and change control throughout the project lifecycle including the verification of consistency, reliability, robustness, and manufacturability for our products
  • Substantiate production and process controls through process validation, process control plans development, and support of statistical process control within operations.
  • Proactively identify potential gaps within the quality system and/or operations processes; corroborating to drive continuous improvement and key decisions utilizing quality tools such as CAPA, SCAR, and other processes
  • Support development and mentor team through relevant quality engineering requirements.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 developing and monitoring the establishment of production and process controls including process validation, process control plans, and statistical process control into manufacturing.
    • Experience applying medical device industry compliance regulations such as CFR 21 Part 820 (QSR) and ISO 13485 to assure appropriate actions, problem solving utilizing technical experience and/or analysis and/or conclusion including tools for risk management and mitigation process (sFMEA, pFMEAs, dFMEAs etc.)
    • Ability to work effectively in a team environment and build strong working relationships, fostering an environment that values diversity and inclusion.
    • Second Shift is 3:00pm to 12:00am. Flexibility needed for the following weekly schedule: Tuesday, Wednesday, Thursday, Friday, Saturday or Sunday, Monday, Tuesday, Wednesday, Thursday.It would be a plus if you also possess previous experience in:
      • A Project Management Certification from a qualified organization such as Project Management Institute (PMI)
      • A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples may include but not limited to 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 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 , Quality Engineer, Sr - 2nd Shift, Other , Lodi, California

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