Senior Quality Engineer

Posted 24 Days Ago
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Duncan, SC, USA
In-Office
Senior level
Biotech
The Role
The Senior Quality Engineer ensures product integrity through quality assurance, manages non-conformance issues, and leads quality improvement initiatives.
Summary Generated by Built In

Bring more to life.

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

At Cytiva, 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.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Senior Quality Engineer is responsible for providing quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and Cytiva standards. This position reports to the Quality Engineering Team Manger and is part of the quality team located in Duncan, SC  and will be an on-site role.

What you will do:

  • Maintain and implement Standard Operating procedures, process flow charts, Process Control Plans, Process FMEA, change controls, and validations.

  • Lead or support site level projects and initiatives ensuring Quality Assurance priorities are fully integrated in operational strategies, and regulatory compliance is maintained.

  • Partner with cross-functional stakeholders to support expansion, risk mitigation and productivity while ensuring product quality.

  • Manage Non-conformance, CAPA and Complaint processes; perform root cause analysis and implement robust corrective actions. Verify effectiveness to prevent recurrence and ensure timely closure.

  • Provide manufacturing quality trend analysis and recommend improvements. Support Kaizen and Shin Kaizen events using Lean manufacturing principles, and Danaher Business System tools to drive continuous improvements.

Who you are:

  • Bachelor’s degree in engineering (e.g. Biomedical, Chemical, Pharma, Industrial, Mechanical, Systems, Quality, Reliability) or equivalent work experience.

  • Experienced in managing quality workflows, including qualification, auditing, change management, CAPA resolution, deviations, and QMS development.

  • Strong interpersonal and communication skills to implement and execute strategies that ensure compliance with regulatory and industry standards.

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

  • Strong problem solving, and root-cause analysis skills with the ability to influence others to drive change (cross-functionally and globally).

  • Experience with electronic QMS platforms (VEEVA, Magic) and SAP Inventory Management preferred.

Cytiva, 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.

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 Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

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.

The U.S. EEO posters are available here.

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:1-202-419-7762 or [email protected].

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The Company
HQ: Sunnyvale, CA
4,883 Employees
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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