Quality Manager - Compliance
Core
Managing quality and regulatory compliance for medical device or drug combination product platforms, ensuring adherence to standards like QSR, GMP, and ISO.
Role type
Quality Manager - Compliance
Builds
compliant medical device and drug combination product platforms
Domain
Medical Device / Pharmaceutical / Regulated Industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance analysis, complaint management, continuous improvement project execution, design validation planning, data analysis for trend identification, concurrent project coordination
Preferred skills
supervisory/managerial experience, experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries
Technologies
Microsoft Excel (AVERAGE, pivot tables)
Responsibilities
Ensure quality and regulatory compliance with applicable regulations (QSR, GMP, ISO); 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
