Director, Quality Assurance, Manufacturing

Responsibilities

• Develop, implement, and direct quality assurance policies, procedures, and methods to improve the quality of complex products and operations.
• Direct all phases of highly technical quality assurance audit activities and oversee Quality Management Systems (QMS) for multiple entities.
• Oversee audits of Distribution Centers, joint ventures, X-Ray Centers, and medical device/pharmaceutical suppliers.
• Monitor supplier performance and recommend process improvements to ensure the quality of materials and components.
• Research and ensure ongoing compliance with FDA, ISO, and ASTM/ANSI standards, including US and International Regulatory Requirements.
• Serve as the FDA Official Correspondent for US facilities and the Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
• Lead, mentor, and develop the quality assurance team to ensure efficient departmental operations.

Requirements

• 12+ years of professional experience with increasing responsibility, including 5+ years in a management role.
• Deep knowledge of ISO 9000 and ISO 13485 certification and maintenance.
• Expertise in European Medical Device Regulation (EU MDR 2017/745) and US FDA Quality Management System Regulation.
• Understanding of MDSAP country-specific regulatory requirements.
• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Ability to travel 25% or more.

Preferred Qualifications

• Master's degree in a relevant field.
• Professional certifications such as RAPS, ASQ, or equivalent.
• Experience managing quality management systems across multiple manufacturing locations.

Benefits

• Medical, Dental, and Vision coverage.
• 401K Plan with company match.
• Paid Time Off (PTO) and Paid Parental Leave.
• Educational benefits and a Worldwide Scholarship Program.
• Income protection and Work Life Assistance Programs.

About the Company

Henry Schein is a Fortune 500 company and a leading global provider of health care products, services, and solutions to office-based dental and medical practitioners. With over 90 years of history, we serve more than 1 million customers in 33 countries, driven by our mission to help health happen.