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 Cepheid Quality Organization and will be located at Lodi, CA. This is an On-site position supporting consumables (mechanical assembly) 24*7 manufacturing operations.

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.

Schedule: Swing shift including weekends (occasional flexibility required)

In this role, you will have the opportunity to:

• Support day to day manufacturing operations, ensuring quality system requirements are being met

• As a liaison for Quality, support manufacturing teams on problem solving, nonconformity process, risk mitigation, and change control that conform to established requirements.

• Proactively identify potential gaps within the quality system and/or operations processes; corroborating to drive continuous improvement utilizing quality tools such as FMEAs, control charts, RCA, fishbone, 5S etc.

• Substantiate production and process controls through process validation, process control plans development, and support of statistical process control within operations.

The essential requirements of the job include:

• Bachelor’s degree with 2+ years of related work experience

• Understanding of quality tools and risk management process

• Ability to work effectively in a team environment and build strong working relationships, fostering an environment that values diversity and inclusion.

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

• Understanding of medical device industry regulations such as CFR 21 Part 820 (QSR) and ISO 13485 to ensure compliance and knowledge of risk management process.

• Experience working at a manufacturing facility (preferably high volume)

• 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 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 danaherbenefitsinfo.com.

The salary range for this role is $59,000 - 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 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, commissio