Senior Quality Operations Engineer - 2nd Shift

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Job description

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. This position is part of our Quality Engineering Team located in Newark, CA.

Second Shift is 3:00pm to 11:00pm. Flexibility needed for the following weekly schedule: Tuesday, Wednesday, Thursday, Friday, Saturday or Sunday, Monday, Tuesday, Wednesday, Thursday.

Learn about the Danaher Business System which makes everything possible.

As a Senior Quality Operations Engineer, you will s upport manufacturing and complaint handling/field sustaining leading to improved compliance with corporate policies, 21CFR820, ISO 13485, the Medical Device Directive, and other applicable regulatory agencies, while striving for continuous improvement. For NPI and Change Control Activities you will ensure that DMRs are complete and accurate as part of NPI/design transfer to manufacturing. Review ECOs and deviations according to change order guidelines, ensuring impact for Major change(s) is outlined and evidence of required activities, and reason for change is clear and accurate. Ensure maintenance of validated state, and consideration for re-validation during various design and process changes, maintenance of product ID and traceability, including that of safety critical parts, review and approve the criteria for WIP reworks and re-inspections and drive improvements in process capability and quality of products.

In this role, you will have the opportunity to:

• Independently plan, coordinate, and report on product quality programs, which provide a basis for sound technical decisions using techniques in experiment design and data analysis.

• Represent QA on development of current business or product improvement projects. Assure accuracy of product labeling and compliance.

• Generate, prepare, and issue complex data for assigned quality reports.

• Provide design review and risk assessment expertise.

• Accept/reject advertising, technical product, and support literature. Identify and/or perform vendor audit or site visits.

• Resolve issues of experimental design and data discrepancy in both intra and interdepartmental experiments.

The essential requirements of the job include:

• BS degree in engineering, technology, or science from an accredited college or university with 5+ years relevant experience OR Master's degree in field with 3+ years' experience or Doctoral degree in field with 0 - 2 years experience.

• Proven track record with system and or reagent product development

• Strong background and experience in NPI Quality for instrumentation hardware and qualification.

• Experience in the application of production and process controls including process validation, process control plans and statistical process control.

• Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.

• Strong analytical skills with FDA, ISO or cGMP experience working in a fast-paced manufacturing.

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

• Certified Quality Engineer

• Experience in biomedical or medical device manufacturing

• Lead Auditor certification

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 .

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

If you've ever wondered what's within you, there's no better time to find out.

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.

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 .

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 to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.