Quality Compliance Audit Manager

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 pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Position Summary

B. Braun Medical Inc., a leader in infusion therapy and healthcare solutions, is seeking a Quality Compliance Audit Manager to lead and support global quality and regulatory compliance initiatives across our manufacturing and operational sites. In this role, you will manage internal and supplier audit programs, drive compliance with FDA and international regulations, and partner with cross-functional teams to ensure the effectiveness of the Quality Management System (QMS). You will serve as a subject matter expert on quality and regulatory requirements while supporting sites during regulatory inspections and certification activities. This position requires strong leadership, project management, and communication skills, along with the ability to influence quality excellence across the organization. This role reports to the Quality organization and may require frequent travel.

In this role, you will have the opportunity to:

• 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.

Essential Requirements

• 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.
• Professional auditing or quality certification preferred (ASQ, ISO Lead Auditor, or equivalent).
• 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.

Preferred Experience

• Medical device, pharmaceutical, or other highly regulated manufacturing environments.
• Supplier quality management and audit program development.
• Regulatory inspection readiness and response management.
• Experience interpreting and implementing global regulatory requirements.

Salary Range- $122,735 - $153,419/ Annual

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.