Quality Engineer

Overview

Quality Engineer (PPE – CAPA / RMA / Validation / ISO 9001)

The Quality Engineer (QE) is responsible for leading PPE product quality investigations, CAPA execution, validation activities, first article inspection (FAI), and process control implementation within an ISO 9001–based Quality Management System. This role supports complaint handling, RMA trending, root cause analysis, and cross-functional corrective action execution.

• Lead investigation of PPE product complaints and RMAs
• Perform structured 8D root cause analysis
• Conduct failure analysis (mechanical, attenuation, material, process-related)
• Track RMA trends and provide monthly quality performance reporting
• Interface with Regulatory Affairs for recall or field action support when required

• Initiate, lead, and close CAPAs in accordance with ISO 9001
• Ensure containment, root cause verification, corrective and preventive action effectiveness
• Maintain CAPA metrics and aging dashboards
• Support audit readiness and CAPA evidence documentation

• Develop and execute validation protocols (IQ/OQ/PQ where applicable)
• Lead material re-qualification activities
• Support process validation for extrusion, lamination, cutting, sewing, or other PPE manufacturing processes
• Ensure traceability of validation data

• Perform or oversee full-scope FAI
• Verify all drawing features and specifications
• Review dimensional, functional, and material verification results
• Approve FAI packages prior to release

• Develop and maintain process control plans
• Implement SPC where applicable
• Monitor critical-to-quality parameters
• Support production with deviation analysis and corrective measures

• Maintain compliance with ISO 9001:2015 clauses (7.1–10)
• Support internal and external audits
• Maintain documented information and objective evidence
• Assist in risk assessment activities

• Bachelor’s degree in Engineering or related technical field
• 5+ years experience in quality engineering (PPE or regulated manufacturing preferred)
• Strong working knowledge of ISO 9001
• Experience with 8D, CAPA systems, root cause analysis tools (5-Why, Fishbone, FMEA)
• Validation protocol writing and execution experience
• FAI experience (AS9102 familiarity preferred but not required)
• Strong analytical and reporting skills

• Technical problem-solving
• Structured investigation methodology
• Data-driven decision making
• Cross-functional leadership
• Regulatory awareness