Quality Engineer (Complaint Handling)

Regulatory Toolkit; South Carolina; On-site; USD 75,000 - 110,000; Full time

Job summary

Cytiva, a Danaher operating company, is seeking a Quality Engineer (Complaint Handling) in Duncan, SC, onsite. You will manage product failures, CAPA, and complaint processes, performing root-cause analyses and implementing robust action plans.

The role collaborates with engineering, quality, manufacturing and customer service; requires a Bachelor's in engineering and 3+ years in regulated environments; proficiency in data analysis and MS Office; Lean Six Sigma a plus.

Qualifications

• Bachelor’s degree in an engineering field 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.

Responsibilities

• Manage product failure/non-conformance, CAPA and Complaint processes; complete root cause analysis and implement robust action plans.
• Follow-up and verification of CAPAs to ensure no recurrence; facilitate timely closures.
• Provide manufacturing quality trend charts/analysis and suggest/implement continuous improvement practices, including kaizen events; roll out DBS related tools to drive improvements.
• Work closely with cross-functional teams/areas: engineering, quality, manufacturing, customer service.

Skills

Data analysis

Problem solving

Risk assessment

Change control

Cross-functional teams

Customer facing interactions

Conflict resolution

MS Office

Education

Bachelor's degree in Engineering

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

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.

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For more information, visit www.danaher.com.

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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].