Advanced Design Quality Engineer
Core
Ensures design control process compliance and validates new product transitions to production using statistical tools and quality plans.
Role type
Senior IC design quality engineer
Builds
Hardware, software, and system designs compliant with regulatory standards
Domain
Medical device manufacturing / Quality Engineering
Required skills
Design Quality Management, Root Cause Analysis, Regulatory Compliance, Statistical Process Control, Risk Management, Technical Documentation, Continuous Improvement, Design Verification Planning, Design Validation Planning, Defect Management
Preferred skills
Six Sigma Green Belt, Data Analysis, Design for Quality (DFQ), CAPA Methodologies, Post Market Surveillance (PMS), Privacy and Security Risk Assessment
Technologies
Statistical tools, Quality planning software, Post-market analytics platforms
Responsibilities
Guide implementation of process validation plans, review quality engineering documents for compliance, propose quality improvement projects, evaluate product designs and perform root cause analysis, validate design inputs (usability, reliability, safety), support quality audits, apply continuous improvement techniques
Seniority
Mid-level to Senior, hands-on IC