Director, Quality (Orthopedics & Vascular Access)

Job Summary

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 organizational transformation.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.