Principal Quality Engineer
Core
Technical lead for complaint investigations and quality system effectiveness in FDA/ISO regulated medical device manufacturing.
Role type
Principal Quality Engineer (Technical Lead)
Builds
Investigation processes, test methods, global quality standards, and CAPA recommendations.
Domain
Medical Devices / Healthcare / Quality Assurance
Required skills
Root cause analysis, data interpretation, regulatory compliance (FDA/ISO), test method development, cross-functional liaison, project management, process improvement, technical documentation, stakeholder communication, strategic planning
Preferred skills
Team leadership, coaching, mentoring, multi-tasking, priority setting
Technologies
None explicitly stated
Responsibilities
Lead large CAPA investigations and develop test methods to identify root causes; Implement and maintain the effectiveness of the quality system; Provide recommendations on product improvements; Set global standards for specifications and drawings; Translate business strategy into day-to-day quality objectives; Act as liaison between Quality, R&D, and Operations; Ensure compliance with regulations regarding complaint investigations; Disseminate investigation results to relevant SMEs.
Seniority
Principal, hands-on IC with strategic oversight