Senior CAPA & Quality Systems Lead

Real; Hanover Township (IN); Vor Ort; USD 120.000 - 165.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plans

Life and disability insurance

Paid leave

Zusammenfassung

Real is seeking a senior CAPA leader to drive corrective and preventive actions across our site portfolio. You will provide technical leadership, oversee investigations, action plans, effectiveness checks, and mentor CAPA team members and contract quality engineers.

You will partner with cross-functional teams for CAPA Review Board activities, keep audit-ready records, and improve Quality System processes, templates, and training while aligning with ISO 13485, 21 CFR 820/QMSR, and MDSAP

Qualifikationen

• Bachelor's degree in Engineering and 8–10 years of relevant experience.
• Leads CAPA investigations, action plans, and effectiveness checks.
• Ensures CAPA outcomes address broader quality system issues across audits and risk management.

Aufgaben

• Lead and drive CAPA activities across the site portfolio.
• Provide technical leadership and oversight of CAPA investigations and action plans.
• Mentor CAPA team members and contract quality engineers.
• Support regulatory and customer audits with inspection readiness and timely responses.

Kenntnisse

CAPA leadership

ISO 13485

21 CFR 820

QMSR

MDSAP

Risk-based decision making

Audit readiness

Gap analysis

FDA/Notified Body audits

Quality systems leadership

Coaching

Training development

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

Real is seeking a senior CAPA leader to drive corrective and preventive actions across our site portfolio. You will provide technical leadership, oversee investigations, action plans, effectiveness checks, and mentor CAPA team members and contract quality engineers.

You will partner with cross-functional teams for CAPA Review Board activities, keep audit-ready records, and improve Quality System processes, templates, and training while aligning with ISO 13485, 21 CFR 820/QMSR, and MDSAP