Quality Engineer - Complaint Handling & CAPA

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

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