Overview

B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Friday, Thursday, Wednesday, Tuesday, MondayShift: 5X8Relocation Available: NoRequisition ID: 12818B. 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 Summary:The Quality Lead I is responsible for providing quality oversight and support for manufacturing operations within a GMP-regulated environment. This role ensures the timely and compliant execution of Quality Control Release Verifications (QCRVs) and Incident Reports (IRs), overseeing workflows that support manufacturing room release and operational continuity. The Quality Lead I reviews manufacturing and quality documentation, coordinates laboratory testing requirements, investigates quality-related issues, and verifies compliance with internal procedures, GMP regulations, and quality system standards.Acting as a key liaison between Quality, Manufacturing, Laboratory Operations, Engineering, and other cross-functional teams, the Quality Lead I applies strong analytical and problem-solving skills to assess quality risks, resolve operational issues, and support manufacturing readiness. The role provides guidance and training to Quality Operations Associates, supports investigations and corrective actions, and ensures quality concerns are appropriately escalated. Success in this position requires advanced knowledge of quality systems, manufacturing processes, documentation practices, and regulatory requirements, along with the ability to work independently while maintaining a high level of accuracy, accountability, and attention to detail. Responsibilities: Essential Duties-Responsible for performing Quality Control Release Verifications (QCRVs) and processing Incident Reports (IRs) to support manufacturing operations while ensuring compliance with applicable procedures, quality standards, and Good Manufacturing Practices (GMP).-Manages the QCRV and IR workflow to ensure laboratory testing requirements are identified, initiated, tracked, and completed before manufacturing rooms are released back to production.-Reviews manufacturing documentation, laboratory testing requirements, and quality records to verify all required activities have been completed prior to authorizing room release.-Interprets and executes quality procedures, work instructions, and manufacturing requirements while ensuring compliance with internal quality systems and regulatory expectations.-Performs detailed research using available quality systems, documentation, historical records, and cross-functional resources to investigate issues, identify required actions, and support timely resolution.-Applies advanced analytical and critical-thinking skills to evaluate complex manufacturing situations, identify potential quality risks, determine appropriate actions, and resolve issues that may impact manufacturing operations.-Provides quality oversight of manufacturing processes to ensure compliance with established procedures, data integrity requirements, and