Dir, QA (Product Quality)
medlineNorthfield, IL
Dir, QA (Product Quality)
L7
medlineNorthfield, ILtoday
Industries
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingOverview:
In this role you lead the Quality organization to ensure compliant products and processes for assigned departments. You translate strategic goals into actionable plans and guide execution to meet long-term quality objectives. You will collaborate with senior leaders, suppliers, and manufacturing partners to maintain high quality, on-time delivery, and customer satisfaction. You will oversee QA programs, audits, and regulatory compliance, influencing cross-functional decisions and continuous improvement. This position offers visibility into shaping quality strategy across a global healthcare business and travel up to 30%. Compensation / Benefits competitive total rewards package health insurance life and disability 401(k) contributions paid time off bonus/incentive eligibility
Responsibilities:
Direct development of product specifications and testing approaches for Medline branded products Partner with Supplier Audit and Division to optimize supplier relationships Develop and implement QA strategy aligned with Quarterly Management Review Prepare and deliver customer and leadership presentations Act as liaison with senior leadership, suppliers, manufacturing, and operations to ensure quality and delivery Collaborate with suppliers and product managers to implement QA programs Oversee QSR compliance via FDA/ISO/internal audits Manage multiple managers and lead strategic, tactical, and operational planning Oversee budgeting for departments and major projects Hire, develop, and evaluate staff, enforce policies
Key requirements:
Bachelor in Engineering, Science, or Technical Field At least 7 years in design/operation of medical device or drug combination product platforms with compliance experience (QSR/GMP/ISO) At least 4 years of management experience Deep knowledge of regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR) Strong data analysis and reporting skills to drive improvements Ability to coordinate multiple concurrent projects and deadlines Advanced Microsoft Excel skills Travel up to 30% leadership and people management cross-functional collaboration strategic thinking QA program development risk management (ISO 14971) quality systems knowledge (QSR/GMP/ISO)
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Level
ManagerL7
Location
Northfield, IL
Occupation
Quality Control Systems Managers
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
today
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