Quality Operations Manager-Ultrasound
Core
Managing quality operations, CAPA processes, and site compliance for ultrasound transducer manufacturing.
Role type
Senior functional manager of quality operations in medical device manufacturing
Builds
Ultrasound transducer manufacturing processes and quality systems
Domain
Medical device manufacturing (Ultrasound)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA management, root cause analysis, process validation, functional team management, regulatory compliance (ISO 13485, 21CFR), data analysis for KPIs, audit management
Preferred skills
ASQ certification
Technologies
ISO 13485, 21CFR, GMP, GDP, PFMEA
Responsibilities
Manage Corrective and Preventive Actions (CAPA) process and non-conformance investigations, oversee quality team management including performance and succession planning, drive supplier quality standards and process validation, ensure site compliance with medical device regulations, lead risk management and continuous improvement initiatives
Seniority
Senior, hands-on IC with functional management responsibilities