Overview

B. Braun Medical, Inc.Company: B. BRAUN MEDICAL (US) INCJob Posting Location: Allentown, Pennsylvania, United StatesFunctional Area: QualityWorking Model: HybridDays of Work: Wednesday, Tuesday, Friday, Thursday, MondayShift: 5X8Relocation Available: NoRequisition ID: 10833B. 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 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 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 job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and others Expertise: Knowledge & SkillsRequires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.Directs the activities of broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees. Determines actual organizational structure and allocation of resources.Judgement is required in resolving complex problems based on experience.Represent