Design Quality Engineer
Core
Support design controls and quality activities for medical device technologies from concept through development, ensuring compliance with regulatory requirements.
Role type
Entry-level Design Quality Engineer
Builds
Safe, reliable medical device technologies
Domain
Medical devices / Regulatory compliance
Required skills
Design control, Design verification, Design validation, Sterilization validation, Process validation, Supplier qualification, Risk management, Statistical analysis, Regulatory compliance (FDA/ISO/IEC), CAPA management
Preferred skills
Statistical background
Technologies
Excel, AI tools
Responsibilities
Support design verification and validation, Develop methods and procedures for product specifications, Support manufacturing operations with risk management and statistical analysis, Ensure compliance with quality and regulatory requirements, Partner with external laboratories and suppliers, Support continuous improvement activities including CAPA and internal audits
Seniority
Junior, 0-2 years experience