Senior Quality Operations Manager-Advanced Imaging
Core
Oversees strategic process validation, CAPA/Nonconformance management, and regulatory compliance for advanced imaging manufacturing operations.
Role type
Senior Quality Operations Manager (Medical Devices)
Builds
Manufacturing quality systems, validated processes, and compliant product transfers
Domain
Medical Devices / Advanced Imaging / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA/ISO 13485 regulatory compliance, CAPA management, root cause analysis, PFMEA, Change/Risk Management (ISO 14971), team leadership, budgeting, workforce planning, supplier quality management, sterilization validation, environmental control programs
Preferred skills
ASQ-CQE certification, ISO Lead Auditor certification, data analytics for PMS
Technologies
None explicitly stated
Responsibilities
Manage talent across the Quality team including performance management and career development; Investigate nonconformances and implement corrective/preventive actions; Plan impact assessments for process changes and assist in manufacturing process development; Oversee testing robustness of product transfer validations; Drive supplier quality standards and cross-functional collaboration; Lead quality engineering tasks and risk management for New Product Introduction
Seniority
Senior, hands-on IC with strategic oversight