Staff Design Quality Engineer
Core
Staff Design Quality Engineer supporting new product development and quality activities throughout the medical device product lifecycle.
Role type
Staff Design Quality Engineer
Builds
Medical devices ensuring compliance with design controls and regulatory requirements
Domain
Medical Devices / Quality Engineering
Required skills
Design control documentation review, Risk management (ISO 14971), Verification and validation, Process validation, Root cause analysis, Quality Management System compliance (ISO 13485, FDA 21 CFR Part 820), Electronic Quality Management Systems
Preferred skills
Certified Quality Engineer (CQE), Class II/III medical device experience, Global regulatory requirements (EU MDR), Statistical analysis, Supplier quality management, Auditing, Software validation
Technologies
Electronic Quality Management Systems
Responsibilities
Represent Quality Engineering on cross-functional new product development teams, Review and approve design control documentation, Apply risk management principles, Support verification, validation, process validation, and design transfer activities, Evaluate product requirements and engineering changes for quality impact, Investigate product issues using root cause analysis, Maintain quality documentation and records, Support internal and regulatory audits
Seniority
Staff, hands-on IC with strategic guidance