Quality Operations Engineer

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 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 and 100% onsite position. Quality Operations Engineering’s vision is to synchronize risk-based quality centric decision making with Cepheid’s “A Better Way” to assure product quality 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 investigation, 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

The essential requirements of the job include:

Bachelor’s degree from an engineering field with 0-2 years of related work experience.

Capability to apply production and process controls including process validation, process control plans, and statistical process control into manufacturing.

Experience in risk management 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.

Expected to be a Thursday to Monday 7am to 4pm shift with flexibility for weekdays as needed.

It would be a plus if you also possess previous experience in:

Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485.

Experience with macro-development

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 danaherbenefitsinfo.com.The salary range for this role is 59,500-81,800. 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 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 www.danaher.com.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 (https://www.dol.gov/agencies/ofccp/posters) .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.Operating Company: Cepheid