Senior Quality Engineer
Core
Ensures product compliance with customer specifications, industry standards, and regulatory requirements; leads quality management system audits and corrective actions.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Quality management systems, validation plans, inspection strategies, and customer quality reports
Domain
Medical device manufacturing / Quality Assurance
Required skills
CAPA development, audit leadership, manufacturing process monitoring, data analysis for quality metrics, inspection strategy design, root cause analysis, cross-functional collaboration, technical training, system design, problem-solving
Preferred skills
Subject matter expertise in assigned systems, coaching and mentoring staff, project leadership
Technologies
Manufacturing software systems, quality management systems (QMS)
Responsibilities
Lead creation and maintenance of Master Validation Plans; serve as primary customer contact for quality issues and audits; monitor manufacturing operations for quality compliance; lead Corrective and Preventive Action (CAPA) discussions and closure; design inspection strategies for receiving, pre-ship, and out-of-box audits; analyze quality metric data to reduce scrap and rework.
Seniority
Senior, hands-on IC