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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll 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 worlds 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:

• Bachelors degree in an engineering or related field (e.g. Industrial Biomedical Molecular Biology Mechanical) with 02 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 its 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 $. 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 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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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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.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .