Principal Engineer

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

We are seeking an experienced Quality Engineer / CAPA professional to take ownership of complex, high-visibility Corrective and Preventive Action (CAPA) activities while helping improve and accelerate the overall CAPA process across the site. This role will provide technical guidance to CAPA personnel, including contract Senior Quality Engineers, while ensuring investigations, corrective action plans, documentation, and effectiveness checks meet quality system requirements. The successful candidate will have strong knowledge of CAPA processes, Quality Management Systems (QMS), regulatory requirements, risk management, and audit readiness within a regulated environment.

Position Details

• Location: Draper, UT
• Schedule: Standard
• Contract Duration: 12 Months
• Max Pay Rate: $58-63/hour

Key Responsibilities

CAPA Management & Leadership

• Take ownership of designated high-complexity and high-visibility CAPAs from investigation through closure.
• Drive improvements and acceleration of the overall CAPA process across the site portfolio.
• Provide guidance, coaching, and day-to-day technical direction to CAPA personnel, including contract Senior Quality Engineers.
• Balance workload across CAPA resources and review:
  • Investigations
  • Corrective action plans
  • Preventive actions
  • Effectiveness checks
• Review CAPA records for completeness and quality before routing for approval.

CAPA Review Board Support

• Support the CAPA Chair in preparing materials for CAPA Review Board meetings.
• Pre-screen CAPA records to ensure they are ready for board review.
• Present CAPA portfolio status, aging, and key issues to stakeholders.
• Track and follow up on CAPA Review Board decisions, action items, and commitments through completion.

Quality System & Compliance

• Support updates and modifications to the site's Quality Management System (QMS).
• Lead or approve revisions to:
  • CAPA procedures
  • Templates
  • Work instructions
  • Training materials
• Perform gap assessments against applicable quality and regulatory requirements, including:
  • ISO 13485
  • 21 CFR 820 / QMSR
  • MDSAP
• Ensure CAPA processes remain aligned with regulatory and quality system expectations.

Documentation & Audit Readiness

• Ensure documentation compliance across the CAPA subsystem.
• Maintain accurate and complete CAPA records with strong:
  • Record integrity
  • Traceability
  • Documentation practices
• Ensure both closed and active CAPA records remain audit-ready.
• Identify documentation gaps and drive appropriate corrective actions.

Risk Management & Systemic Issue Assessment

• Apply risk-based decision-making when evaluating systemic nonconformities.
• Assess potential impacts to:
  • Quality Management System
  • Products
  • Processes
  • Regulatory compliance
• Determine the appropriate scope and depth of corrective actions based on risk and potential impact.
• Ensure CAPA activities address systemic issues rather than only individual occurrences.

Quality System Integration

• Connect CAPA outcomes with other quality system processes, including:
  • Customer complaints
  • Nonconformances (NCs)
  • Internal and external audit findings
  • Risk management
  • Management Review
• Identify relationships between quality events and systemic issues.
• Drive appropriate actions to close identified quality system gaps.

Audit & Inspection Support - Preferred

• Serve as a CAPA Subject Matter Expert (SME) during:
  • FDA inspections
  • Notified Body audits
  • Customer audits
• Defend CAPA records and explain investigation and corrective action decisions.
• Support the preparation and negotiation of audit responses.
• Manage audit-related CAPA commitments and follow-up activities through closure.

Required Qualifications

• Bachelor's degree in Engineering is required.
• 8-10 years of relevant professional experience required.
• Strong experience managing complex CAPA investigations and corrective action activities.
• Experience working within a regulated Quality Management System.
• Strong understanding of risk-based quality decision-making.
• Experience with quality system documentation, compliance, and audit readiness.
• Strong communication, leadership, and organizational skills.
• Ability to provide technical direction and guidance to other quality professionals.

Preferred Experience

• Experience supporting FDA inspections and regulatory audits.
• Experience with ISO 13485, 21 CFR 820/QMSR, and MDSAP.
• Medical device or other highly regulated industry experience.
• Experience serving as a CAPA or Quality Systems SME.
• Experience with quality system integration across complaints, nonconformances, audits, risk management, and Management Review.

Key Attributes

The successful candidate will:

• Take ownership of complex CAPAs and drive them through timely closure.
• Be comfortable providing technical direction to other Quality Engineers.
• Identify systemic issues and apply a risk-based approach to corrective action.
• Communicate quality risks clearly to leadership and cross-functional teams.
• Maintain a high standard of documentation and regulatory compliance.
• Be comfortable working with auditors, regulatory bodies, and senior stakeholders.
• Bring structure and accountability to a complex CAPA portfolio.

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