Site Quality Manager
Core
Develop and implement quality policies and processes to ensure medical device products and services comply with regulatory standards and specifications.
Role type
Site Quality Manager
Builds
Medical device manufacturing operations compliant with FDA, ISO 13485, and MDSAP standards
Domain
Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance management, audit leadership, team management, root cause analysis, CAPA management, document control, risk management, supplier qualification, design control oversight, KPI reporting
Preferred skills
experience managing hourly and salary professionals, root cause analysis expertise, documentation control proficiency
Technologies
ISO 13485, FDA QSR, MDSAP, FMEA
Responsibilities
Develop and implement quality policies and processes; Provide strategic oversight and leadership to direct reports; Lead audit readiness and facilitate regulatory audits (FDA, MDSAP); Manage internal and external audits; Oversee document control, CAPA, and complaint handling; Support risk management activities including hazard analysis; Collaborate with engineering and production teams; Train and mentor staff on quality procedures.
Seniority
Manager, supervises professional employees and front-line supervisors
