USAAllentown VP, QA Franchise (Med Device) PA 18109

Job description

VP, QA Franchise (Med Device) 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 cross‑functional 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 executive‑level reporting on device quality performance, compliance risks, manufacturing site status, and key project milestones. Coordinate FDA‑required and global post‑market surveillance activities, including complaint handling, vigilance reporting, trend analysis, and field corrective actions, in partnership with Corporate PMS. Champion a strong medical device quality culture and support harmonization of a unified corporate QMS across all device operations and manufacturing sites. Develop and manage the franchise quality budget, including staffing, operational expenses, supplier quality oversight, and special compliance or remediation projects. Serve as the primary liaison with regulatory authorities during medical device inspections, audits, and communications related to product quality, compliance issues, and site performance. Partner closely with Regulatory Affairs, Engineering, and R&D to ensure that process development, and manufacturing adhere to quality standards. 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. 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 .