Senior Quality Engineer: CAPA & QMS Specialist

Real Staffing; Saint Paul (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Real Staffing is seeking a Senior Quality Engineer to drive CAPA and QMS improvements in a regulated environment. The role emphasizes hands-on leadership ensuring timely CAPA closure, NCR oversight, and robust root cause analysis across cross-functional teams.

The successful candidate will maintain and improve QMS procedures, support internal and external audits, and apply data-driven approaches to enhance product quality and compliance within a fast-paced setting.

Qualifications

• Bachelor's degree in Engineering, Quality, or related field.
• 5–8+ years of quality engineering experience in regulated environments.
• Deep CAPA and NCR systems experience.
• Strong root cause analysis and data-driven problem solving.
• Hands-on QMS maintenance and regulatory knowledge.

Responsibilities

• Lead end-to-end CAPA processes including initiation, investigation, implementation, and effectiveness verification.
• Review, disposition, and manage Nonconformance Reports (NCRs) with cross-functional collaboration.
• Conduct structured root cause investigations to drive corrective actions.
• Support development and maintenance of the Quality Management System (QMS) and regulatory audits.
• Drive continuous improvement initiatives using data analysis and quality tools.

Skills

CAPA management

NCR handling

Root cause analysis

QMS maintenance

Regulatory knowledge

Data analysis

Education

Bachelor's degree in Engineering/Quality

Tools

eQMS software

Job description

Real Staffing is seeking a Senior Quality Engineer to drive CAPA and QMS improvements in a regulated environment. The role emphasizes hands-on leadership ensuring timely CAPA closure, NCR oversight, and robust root cause analysis across cross-functional teams.

The successful candidate will maintain and improve QMS procedures, support internal and external audits, and apply data-driven approaches to enhance product quality and compliance within a fast-paced setting.