Dir Manufacturing Quality
Core
Lead the Quality team to ensure product and process compliance for Medline medical devices and drug combination products, developing strategies and executing long-term goals.
Role type
Senior Director of Manufacturing Quality
Builds
Quality strategies, product specifications, supplier relationships, and QA programs for medical device and drug combination products
Domain
Medical Devices / Pharmaceutical / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, budget management, team leadership, regulatory compliance (QSR/GMP/ISO), supplier relationship management, data analysis, project coordination
Preferred skills
6+ years managerial experience, 8+ years in Medical Device/Pharmaceutical/Food/Cosmetic industries
Technologies
Microsoft Excel (pivot tables, AVERAGE, merging cells)
Responsibilities
Direct development of product specifications and testing procedures; Partner with Supplier Audit to optimize supplier relationships; Develop and implement Quality department strategy based on Quarterly Management Review; Prepare and deliver customer presentations; Act as liaison with Senior Leadership, Suppliers, and Operations; Oversee QSR and ensure compliance with FDA/ISO/internal audits; Manage multiple managers, budgets, hiring, performance reviews, and strategic planning (12+ months)
Seniority
Director, strategic & operational leadership