Quality Operations Engineer

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cepheid, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

The Quality Operations Engineer supports day-to-day Manufacturing Quality activities by completing structured assignments using established procedures and under the guidance of senior Quality Engineering staff to help maintain compliance with the Quality Management System (QMS) and applicable regulations. This role contributes to product quality and sustaining operations by supporting investigations, documentation updates, and process improvement activities.

This position reports to the Manager, Manufacturing Quality and is part of the Cepheid Quality Operations Team located in Lodi, California. This is an ON-SITE role supporting twenty-fourx7 manufacturing operations.

Schedule:

5 days (Monday - Friday) - Day Shift

In this role, you will have the opportunity to:

* Quality point of contact assisting with day-to-day inquiries and escalations; gather information, document issues, and escalate to senior Quality/Manufacturing leadership as needed.

* Participate in quality system and process improvement activities by collecting data, performing trending, and supporting GEMBA and problem-solving activities using established tools and templates.

* Work with engineering and manufacturing teams to support process improvements and variability reduction by executing assigned tasks (e.g., data collection, document updates, and follow-up actions) under guidance.

* Support process validations, process control plans, and statistical process control (SPC) activities by following documented protocols/work instructions and accurately recording results.

* Support project teams by updating and maintaining quality documentation (e.g., inspection and manufacturing documents, test methods, and Device History Records (DHRs)) using established templates and review processes.

* Support compliance activities related to design control and change control by preparing documentation, routing records for review/approval, and following established procedures.

The essential requirements of the job include:

* Bachelor's degree in an engineering or related field (e.g., Industrial, Biomedical, Molecular Biology, Mechanical), with 0-2 years of related experience (internship/co-op experience may be considered)

* Foundational understanding of quality concepts and tools (or demonstrated ability to learn them quickly) and the ability to follow documented procedures in a regulated environment

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

* Exposure to medical device or diagnostics regulations/standards (e.g., 21 CFR Part 820 and ISO 13485) and interest in learning how they are applied in manufacturing quality.

* 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 are 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 Danaher Benefits Info.

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team.

Explore the flexibility and challenge that working for Cepheid can provide.

The annual salary range for this role is $70,500 - 85,000. 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.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off,…