Prin Engr

Real; Hanover Township (IN); In loco; USD 120.000 - 165.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Retirement plans

Life and disability insurance

Paid leave

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

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

Formazione

Bachelor's degree in Engineering

Descrizione del lavoro

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.