Quality Manager - Design Quality Engineering
Core
Lead a team of Design Quality Engineers to provide guidance on Design Controls, regulations, and internal processes to engineering teams, ensuring robustness in medical device design.
Role type
Senior IC Quality Manager (Design Quality Engineering)
Builds
Medical device designs compliant with EU-MDR and FDA regulations
Domain
Medical Devices / Regulatory Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Controls, CAPA, Reliability, Root Cause Analysis, FMEA, Safety Risk Management, Verification vs. Validation, Requirements Development, Statistical Analysis, Post Market Risk Assessment
Preferred skills
EU-MDR, 21CFR820, ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, ASQ CQE/CRE/CQM certifications
Technologies
FMEA Handbook, Statistical Tools, Trending Analysis
Responsibilities
Lead a team of Design Quality Engineers, Act as a Super User for Design Controls processes, Support engineering teams throughout the development lifecycle, Lead statistical analysis for product reliability and rare events, Perform Post Market Risk Assessment, Facilitate Design Failure Modes Effects Analysis (FMEA)
Seniority
Senior, hands-on IC with people management