
Quality Compliance Audit Manager - 14177
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Job overview
B. Braun Medical is seeking a Quality Compliance Audit Manager to lead global quality and regulatory compliance initiatives across manufacturing and operational sites. The role manages internal and supplier audit programs, supports FDA and international regulatory compliance, and partners with cross-functional teams on the Quality Management System. It also serves as a subject matter expert and supports regulatory inspections and certification activities; frequent travel may be required.
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Full job description
B. Braun Medical, Inc. 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 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®. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com 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 View the full job description on the employer's website. Equal employment opportunity, including veterans and individuals with disabilities. PI287349869 / 11-9199.02 Compliance Managers
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