Senior CAPA & Quality Systems Engineer

Real Staffing Group; Virginia (MN); On-site; USD 140,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plan

Life and disability insurance

Paid leave

Job summary

Real Staffing Group is seeking a senior CAPA leader to drive corrective and preventive actions across complex quality issues. You will mentor teams, oversee investigations, and ensure compliance readiness across the site portfolio.

Strong collaboration with cross-functional partners is essential. You will apply risk-based decision making, support audit responses, and contribute to improving quality systems, templates, and training materials in line with ISO 13485, 21 CFR 820, and MDSAP

Qualifications

• Bachelor's degree in Engineering.
• 8-10 years of relevant experience.
• Ability to lead CAPA investigations and cross-functional teams.

Responsibilities

• Lead and drive CAPA activities for timely resolution of systemic quality issues.
• Provide technical leadership and oversight of investigations, action plans and effectiveness checks.
• Mentor CAPA team members and contract quality engineers; support regulatory audits.

Skills

CAPA Leadership

Audit Readiness

Risk-Based Decision Making

Quality Systems

Education

Bachelor's degree in Engineering

Tools

ISO 13485

FDA Audits

Notified Bodies

QMSR

Job description

Real Staffing Group is seeking a senior CAPA leader to drive corrective and preventive actions across complex quality issues. You will mentor teams, oversee investigations, and ensure compliance readiness across the site portfolio.

Strong collaboration with cross-functional partners is essential. You will apply risk-based decision making, support audit responses, and contribute to improving quality systems, templates, and training materials in line with ISO 13485, 21 CFR 820, and MDSAP