Quality Engineer (Complaint Handling)

Regulatory Jobs; Duncan (SC); On-site; USD 70,000 - 105,000; Full time

Benefits offered by this job

Bonus/incentive pay

Medical/dental/vision insurance

401(k) retirement plan

Job summary

Cytiva, a Danaher operating company, seeks a Quality Engineer (Complaint Handling) to drive quality adherence in a high-volume facility in Duncan, SC. The role emphasizes CAPA, root-cause analysis, and robust action plans, with collaboration across engineering, manufacturing and customer service.

Requirements include a bachelor’s in engineering and 3+ years in regulated environments, strong data analysis skills, and proficiency with MS Office; Lean/Six Sigma and Veeva/SAP/Magic experience are a

Qualifications

• Bachelor’s degree in an engineering field with 3+ years in manufacturing or regulated environments.
• Proficiency with data analysis and applying tools in problem solving, risk assessment, process validation and change control.
• Ability to work with cross-functional teams and manage customer-facing interactions.

Responsibilities

• Manage product failure/non-conformance, CAPA and complaint processes with root-cause analysis.
• Follow-up and verification of CAPAs to prevent recurrence and close actions timely.
• Provide quality trend analysis and support continuous improvement initiatives using lean methods.
• Collaborate with engineering, quality, manufacturing and customer service teams.

Skills

Data analysis

Problem solving

Risk assessment

Process validation

Change control

Cross-functional teams

Customer facing

MS Office

Lean manufacturing

Education

Engineering degree

Tools

Veeva

SAP

Magic (Enovia)

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 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 Quality Engineer (Complaint Handling) for Cytiva is responsible for driving quality adherence, process change and risk assessment in a high volume manufacturing facility.

This position is part of the Quality Assurance Team reporting to the Quality Team Manager located in Duncan, SC and will be an on‑site position.

What you’ll do:

• Manage product failure/non‑conformance, CAPA and Complaint (internal and external) processes; complete root cause analysis and effectively implement robust action plan.
• Follow‑up and verification of CAPAs to ensure no recurrence. Facilitate the closures of these in a timely manner.
• Provide manufacturing quality trend charts/analysis and suggest/implement continuous improvement practices, including appropriate kaizen events on relevant processes based on trends; support Shin Kaizen events and use Lean manufacturing principles, as and when required. Roll out CDT&R, VOC, DRS, PSP, FMEA- utilize DBS to drive continuous improvements.
• Work closely with cross‑functional teams/areas: engineering, quality, manufacturing, customer service.

Who you are:

• Bachelor’s degree in an engineering field (e.g. Biomedical, Chemical, Pharma, Industrial, Mechanical, Systems, Quality, Reliability) with 3+ years of experience in a manufacturing or highly regulated environment.
• Proficiency with data analysis and applying tools in problem solving, risk assessment, process validation and change control.
• Proven agility working with cross‑functional teams.
• Demonstrated experience in customer facing interactions and conflict resolution.
• Proficient with Microsoft Office: Outlook, Teams, Excel, and Word.

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

• Lean Six Sigma
• Knowledge of the following software/systems: Veeva, SAP, Magic (Enovia).
• Technical writing

Benefits

• Cytiva,a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
• 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.

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.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click 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 [e-mail].

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