Director of Quality Management System & Compliance - Remote

Overview

The Director of Quality Management System is responsible for ensuring that BD PI entities worldwide have a robust quality management system that meets/exceeds the applicable regulatory requirements.

In Short

• Lead all aspects of global entities to harmonize quality management systems.
• Drive design and implementation of QMS processes aligned with business objectives.
• Ensure compliance with regulatory standards across different sites.
• Develop and maintain a program for global regulatory changes.
• Lead team to accomplish annual compliance goals.
• Participate in external audits and develop remediation plans.
• Promote a culture of quality within the organization.
• Manage staff and develop future quality leaders.
• Utilize metrics dashboard for compliance monitoring.
• Engage with Notified Bodies and Regulatory Authorities.

Requirements

• 10+ years of experience in QA leadership or corporate QMS.
• BS degree in a technical field.
• Expert knowledge of FDA QSR, ISO-13485, EU MDD, EU MDR.
• Excellent communication skills and ability to influence.
• Experience in a matrix environment.
• Knowledge of US and International regulations for medical devices.
• Effective analytical and problem-solving skills.
• Willingness to travel globally.
• Experience with QMS software and technical writing.

Benefits

• Supportive work environment for personal and professional growth.
• Culture that values opinions and contributions.
• Opportunities to learn and improve daily.
• Equal Opportunity/Affirmative Action Employer.