Staff Quality Engineer

Job Description

Position Summary

The Staff Quality Engineer is responsible for leading and sustaining the Corrective and Preventive Action (CAPA) process to ensure timely, effective, and compliant resolution of quality issues. This role drives root cause analysis, risk-based decision-making, and continuous improvement initiatives while maintaining adherence to internal policies, procedures, and regulatory requirements. The individual will collaborate across functions and work independently to design, implement, and optimize quality system solutions that enhance product reliability and process performance.

Responsibilities and Duties

• Support company goals, objectives, policies, and procedures to ensure alignment with quality and regulatory standards.
• Lead and manage the entire CAPA lifecycle, including initiation, investigation, action planning, implementation, and effectiveness verification.
• Serve as Subject Matter Expert (SME) for root cause analysis; provide guidance and training on structured problem-solving tools such as 5 Whys, Fishbone (Ishikawa), and Fault Tree Analysis to eliminate systemic issues.
• Perform and support risk assessments (e.g., FMEA) and integrate risk management principles into CAPA activities and sustaining engineering changes.
• Identify, prioritize, and implement proactive quality improvements to prevent recurrence of issues and enhance process robustness.
• Collect, analyze, and trend CAPA and quality system metrics to identify patterns, drive continuous improvement, and report findings to management.
• Communicate CAPA findings, progress, and outcomes effectively across cross-functional teams, ensuring transparency and accountability.
• Create, revise, and review Standard Operating Procedures (SOPs) and related documentation to maintain compliance with latest regulatory standards
• Assist with internal audits and management reviews, ensuring readiness for external inspections and regulatory audits.

Requirements

Salary Range : $154,000 - $165,000