Global Quality Compliance Audit Leader (FDA/ISO)

B. Braun Medical Inc. (US); Bethlehem (Northampton County); On-site; USD 123,000 - 153,000; Full time

Job summary

B. Braun Medical Inc., a leader in infusion therapy and healthcare solutions, seeks a Quality Compliance Audit Manager to lead and support quality and regulatory initiatives across manufacturing and site operations.

You will manage internal and supplier audits, drive FDA/ISO/MDSAP compliance, and partner with cross-functional teams to strengthen the QMS. The role requires strong leadership, project management, and communication skills, and may require frequent travel to support audits and

Qualifications

• Bachelor’s degree in a scientific, engineering, or related discipline; Master’s degree preferred.
• 10+ years of experience in Quality, Regulatory Affairs, Compliance, Auditing, or a related regulated industry.
• Strong knowledge of FDA regulations, ISO 13485, MDSAP, and global quality systems.
• Demonstrated experience leading audits, regulatory inspections, and compliance improvement initiatives.
• Excellent project management, communication, and cross-functional leadership skills.
• Ability to travel frequently to support audits and site compliance activities.

Responsibilities

• Lead internal and supplier audit programs to ensure compliance with FDA, ISO, MDSAP, and other global regulatory requirements.
• Conduct gap assessments of new and revised regulations and drive implementation projects across sites.
• Partner with manufacturing and quality teams to maintain and continuously improve the Quality Management System.
• Support regulatory inspections, third-party audits, and certification activities, including audit preparation and response management.
• Develop and deliver training programs to strengthen compliance knowledge and audit readiness across the organization.
• Monitor quality system certifications and collaborate with notified bodies to maintain compliance status.
• Provide expert guidance on regulatory trends, industry best practices, and quality compliance strategies.

Skills

Project management

Communication

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering

Master’s degree preferred

Tools

ASQ

ISO Lead Auditor

Job description

B. Braun Medical Inc., a leader in infusion therapy and healthcare solutions, seeks a Quality Compliance Audit Manager to lead and support quality and regulatory initiatives across manufacturing and site operations.

You will manage internal and supplier audits, drive FDA/ISO/MDSAP compliance, and partner with cross-functional teams to strengthen the QMS. The role requires strong leadership, project management, and communication skills, and may require frequent travel to support audits and