Prin Engr

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

Lead and drive complex, high-impact Corrective and Preventive Action (CAPA) activities to ensure timely resolution of systemic quality issues across the site portfolio. Provide technical leadership and oversight of CAPA investigations, action plans, effectiveness checks, and compliance readiness, while mentoring CAPA team members and contract quality engineers.

Partner with cross-functional teams to support CAPA Review Board activities, maintain audit-ready records, and improve Quality System processes, procedures, templates, and training materials. Conduct gap assessments against ISO 13485, 21 CFR 820/QMSR, and MDSAP requirements, apply risk-based decision-making, and ensure CAPA outcomes effectively address broader quality system issues, including complaints, audits, nonconformances, and risk management.

Serve as a quality subject matter expert during regulatory and customer audits, supporting inspection readiness, audit responses, and follow-through on corrective actions.

Requirements: Bachelor's degree in Engineering and 8-10 years of relevant experience.

Key Skills: CAPA, ISO 13485, 21 CFR 820, QMSR, MDSAP, Risk-Based Decision Making, Audit Readiness, Gap Analysis, FDA/Notified Body Audits, Quality Systems Leadership, Coaching, and Training Development.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.