Senior Manager QA (Medtech)
Core
Lead QA Design Control and Supplier Quality initiatives to ensure safe, compliant, and innovative medical devices during new product development and maintenance.
Role type
Senior Manager, QA Design Control
Builds
Immunoassay, Blood Gas, Transcutaneous monitoring, and IT System solutions for global healthcare
Domain
Medtech / Life Sciences / Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, Supplier quality management, Risk management (ISO 14971), Usability engineering, Requirement traceability, Audit readiness, Regulatory compliance (FDA, ISO 13485, IEC 60601-1), Team leadership, Lean process development
Preferred skills
Immunoassay principles (ELISA, chemiluminescence, lateral flow), Product lifecycle management for immunoassay devices, System engineering concepts, Data analysis tools
Technologies
FDA 21 CFR 820, ISO 13485, ISO 14971, MDR, IVDR, IEC 60601-1
Responsibilities
Lead and manage QA professionals and supervisors; Drive operational excellence and resource planning; Provide technical leadership in design control; Champion risk-based decisions and compliance; Collaborate across functions and globally; Lead supplier quality management; Represent QA leadership in strategic forums
Seniority
Senior Manager, hands-on leadership