Manager QA
Core
Manage quality and regulatory compliance for medical device or drug combination product platforms, ensuring adherence to standards like QSR, GMP, and ISO.
Role type
Manager, Quality Assurance & Regulatory Compliance
Builds
Quality products and compliant processes for medical devices and drug combinations
Domain
Medical Devices / Pharmaceuticals / Regulated Industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance (QSR, GMP, ISO), risk management, data analysis, project coordination, policy interpretation, staff management, budget contribution
Preferred skills
Supervisory/managerial experience, experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries
Technologies
Microsoft Excel (pivot tables, AVERAGE, merging cells)
Responsibilities
Ensure quality and regulatory compliance with applicable regulations; Act as a liaison with Divisions, Suppliers, Manufacturing, and Operations; Manage complaints and develop problem-solving approaches; Identify and manage continuous improvement projects; Assist in planning design, testing, inspection, and process validations; Resolve quality issues to customer satisfaction; Oversee professional or non-professional employees; Interpret and execute departmental policies; Hire staff, conduct performance reviews, and assign work.
Seniority
Manager, hands-on leadership with team oversight
