VP, QA Franchise (Med Device) - 10833

B. Braun Medical, Inc. Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Allentown, Pennsylvania, United States Functional Area: Quality Working Model: Hybrid Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 10833 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: Responsibilities: Essential Duties Provide strategic leadership for all franchise Quality Assurance functions to ensure compliance with global medical device regulations, including 21 CFR 820, ISO 13485, EU MDR, CMDR, CFDA, and PMDA. Ensure medical devices are designed, validated, manufactured, and distributed in accordance with Design Control requirements, risk management principles (ISO 14971), and BBMI quality standards. Partner with Business Unit leadership to integrate quality and regulatory expectations into product development, manufacturing operations, and lifecycle management. Represent Corporate Quality in franchise leadership forums, design reviews, manufacturing site assessments, and crossfunctional project teams for device programs. Develop, maintain, and report medical device--specific quality metrics (e.g., NC/CAPA trends, complaint rates, audit findings, field actions) to drive continuous improvement across the QMS. Provide executivelevel reporting on device quality performance, compliance risks, manufacturing site status, and key project milestones. Coordinate FDArequired and global postmarket surveillance activities, including complaint handling, vigilance reporting, trend analysis, and View the full job description on the employer's website. Equal employment opportunity, including veterans and individuals with disabilities. PI287044575 / 11-9199.01 Regulatory Affairs Managers