Quality Compliance Audit Manager
Company: B. BRAUN MEDICAL (US) INC
Job Posting Location: Bethlehem, Pennsylvania, United States
Functional Area: Quality
Working Model: Remote
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 14177
Position SummaryB. 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
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
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.
