Dir, QA (Product Quality)
Core
Lead Quality teams to ensure product quality and compliance for Medline branded medical device and drug combination products.
Role type
Director of Product Quality (Strategic leadership)
Builds
Quality strategies, testing procedures, supplier qualification programs, and compliance frameworks for regulated medical products.
Domain
Medical Devices / Pharmaceuticals / Regulated Industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, supplier relationship management, FDA/ISO compliance oversight, budget management, team leadership, risk management, data analysis
Preferred skills
6+ years managerial experience, 8+ years in Medical Device/Pharma/Food/Cosmetic industries
Technologies
Microsoft Excel (pivot tables, data analysis)
Responsibilities
Develop product testing specifications and supplier qualification methods; Partner with Supplier Audit to optimize supplier relationships; Oversee QSR compliance for FDA/ISO/internal audits; Manage departmental budgets and strategic planning; Lead hiring, performance reviews, and staff development; Present to customers and senior leadership.
Seniority
Director, manages multiple managers