Cepheid

life sciences, diagnostics and biotechnology

QualityOperationsEngineer

$71–85k Lodi, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Entry candidates.

The Brief

“Quality Operations Engineer at Cepheid. Skills: Quality Operations, Manufacturing Quality, Process Improvement, QMS Compliance. Support day-to-day Manufacturing Quality activities. Complete structured assignments using established procedures”

What You'll Achieve.

Contribute to product quality; Contribute to sustaining operations; Help maintain compliance with the Quality Management System (QMS) and applicable regulations

Industry & Context.

life sciences, diagnostics and biotechnology
Problems you'll solve

Problem-solving activities; Variability reduction

Eligibility Requirements

ON-SITE role, Supporting twenty-fourx7 manufacturing operations

What They're Looking For.

Must Have

Bachelor's degree in an engineering or related field (e.g., Industrial, Biomedical, Molecular Biology, Mechanical), 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), Ability to follow documented procedures in a regulated environment

Nice to Have

Exposure to medical device or diagnostics regulations/standards (e.g., 21 CFR Part 820 and ISO 13485), Interest in learning how regulations/standards 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 (e.g., CQE, CRE, CQA)

What You'll Do.

Support day-to-day Manufacturing Quality activities

Complete structured assignments using established procedures

Maintain compliance with the Quality Management System (QMS) and applicable regulations

Support investigations

Support documentation updates

Support process improvement activities

Serve as Quality point of contact for day-to-day inquiries

and escalate to senior Quality/Manufacturing leadership

Participate in quality system and process improvement activities

Support GEMBA and problem-solving activities

Support process improvements and variability reduction

Execute assigned tasks (e.g.

and follow-up actions)

Support process validations

Support process control plans

Support statistical process control (SPC) activities

Support project teams by updating and maintaining quality documentation (e.g.

inspection and manufacturing documents

and Device History Records (DHRs))

Support compliance activities related to design control and change control

How You'll Work.

Team & Collaboration

Work with engineering and manufacturing teams; Support project teams; Escalate to senior Quality/Manufacturing leadership

Full Job Description

**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](https://danaher.com/our-businesses) 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](https://www.danaher.com/how-we-work/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 informatio

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