Senior CAPA & Quality Systems Lead

Hydrogen Group; Draper (UT); On-site; USD 80,000 - 87,000; Full time

Job summary

Hydrogen Group seeks an experienced Quality Engineer / CAPA professional to own complex CAPA activities and guide CAPA personnel in a regulated environment. You will ensure investigations, corrective actions, and effectiveness checks meet quality system requirements and audit readiness.

Responsibilities include leading CAPA investigations, coordinating with CAPA leadership, and aligning CAPA processes with ISO 13485 and 21 CFR standards while maintaining thorough documentation and risk-based

Qualifications

• Bachelor's degree in Engineering is required.
• 8–10 years of relevant professional experience.
• Experience in regulated Quality Management System (QMS).
• Strong understanding of risk-based quality decision-making.
• Excellent communication, leadership and organizational skills.
• Ability to provide technical direction to CAPA personnel.

Responsibilities

• Own high-complexity CAPAs from investigation through closure.
• Drive improvements and acceleration of the CAPA process across the site.
• Provide guidance to CAPA personnel, including contract Senior Quality Engineers.
• Review CAPA records for completeness and quality before routing for approval.
• Support the CAPA Review Board meetings and present portfolio status.

Skills

CAPA management

Leadership

Risk-based decisions

Regulatory compliance

Documentation

Audit readiness

Education

Bachelor's degree in Engineering

Job description

Hydrogen Group seeks an experienced Quality Engineer / CAPA professional to own complex CAPA activities and guide CAPA personnel in a regulated environment. You will ensure investigations, corrective actions, and effectiveness checks meet quality system requirements and audit readiness.

Responsibilities include leading CAPA investigations, coordinating with CAPA leadership, and aligning CAPA processes with ISO 13485 and 21 CFR standards while maintaining thorough documentation and risk-based