Director, Quality; Orthopedics & Vascular Access

Position: Director, Quality (Orthopedics & Vascular Access)
Job Summary Medline is seeking a Director of Product Quality to lead a team supporting our Orthopedics and Vascular Access businesses. This leader will serve as the primary Quality partner to divisional leadership, translating customer and business needs into product specifications, testing requirements and development priorities.

The role focuses on premarket product development and partners closely with specialized Quality teams, suppliers and Operations to support successful product transfer and ongoing product quality. As Medline’s Quality organization evolves, this director will help build new ways of working, clarify responsibilities and lead teams through change.

Job Description Major Responsibilities Lead product Quality strategy for the Orthopedics and Vascular Access businesses, aligning technical priorities with customer needs and business objectives.

Direct the development of product specifications, tolerances, testing requirements and methods for evaluating and qualifying new products.

Partner with product managers, divisional leaders and technical specialists to translate customer needs into measurable product requirements.

Provide Quality leadership throughout product development, including design controls, risk management, verification, validation and design transfer.

Serve as the primary Quality liaison for assigned divisions, influencing decisions, communicating risks, resolving barriers and coordinating priorities across functions.

Collaborate with Supplier Quality, Supplier Audit, suppliers, manufacturing partners and Operations to support product qualification and transfer.

Maintain engagement across the product lifecycle, coordinating with the functions responsible for supplier, manufacturing and postmarket quality.

Ensure applicable development activities and documentation comply with FDA requirements, ISO standards and internal quality procedures.

Lead and develop managers and quality engineers, including hiring, performance management, coaching, succession planning and resource allocation.

Develop departmental plans, budgets and performance measures; use data and management reviews to drive improvement.

Prepare and deliver presentations to customers, business partners and senior leadership.

Lead through organizational change, establishing clear priorities and accountability in a dynamic environment.

Minimum Qualifications Bachelor’s degree in Engineering, Science or a related technical field.

At least seven years of medical device experience involving product development, design controls, risk management or related quality engineering activities.

Experience supporting orthopedic or vascular access medical devices.

At least four years of people management experience.

Strong technical knowledge of applicable FDA quality system requirements, ISO 13485, ISO 14971, MDSAP and EU MDR.Demonstrated ability to translate customer and business needs into product specifications and testing requirements.

Ability to influence business and technical leaders, communicate complex issues clearly and drive decisions across functions.

Experience managing concurrent projects, competing priorities and critical deadlines.

Ability to lead teams through change and work effectively where processes and responsibilities are evolving.

Proficiency in data analysis, reporting and Microsoft Excel.

Ability to travel up to 30%, domestically and internationally.

Preferred Qualifications At least eight years of medical device experience and six years of management experience.

A foundation in product development or engineering, with progression into Quality leadership.

Experience leading managers and engineers across multiple product portfolios.

Experience establishing or improving Quality processes during…