Quality Lead I (Irvine)
B. Braun Medical, Inc. Company: B. Braun US Pharmaceutical Manufacturing LLC Job Posting Location: Irvine, California, United States Functional Area: Quality Working Model: Onsite Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 12818 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: 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 quality system expectations. -Coordinates and communicates effectively with laboratory personnel, manufacturing associates, supervisors, managers, engineers, and other cross-functional departments to facilitate testing completion, issue resolution, and manufacturing continuity. -Provides routine work direction, coaching, and training to Quality Operations Associates regarding quality systems, QCRV processing, -Incident Report management, and manufacturing support activities. -Escalates quality concerns, testing delays, compliance risks, or manufacturing issues to Quality Management as appropriate. -Supports quality investigations by gathering information, reviewing documentation, identifying potential root causes, and assisting with implementation of corrective actions. -Performs additional quality-related responsibilities as assigned by management to support business objectives and manufacturing operations. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. Expertise: Qualifications - Experience/Training/Education/Etc Required: -Bachelor’s degree in a science, engineering, or related technical field preferred. -Or six years of experience in Quality Assurance, Quality Operations, Manufacturing, Laboratory Operations, or a related GMP-regulated environment. -Demonstrated experience managing Quality Control and Incident Reports, manufacturing documentation, and quality system workflows. -Strong understanding of GMP regulations, documentation practices, manufacturing processes, laboratory testing requirements, and quality systems. -Proven ability to interpret technical procedures, perform investigations, conduct research, and communicate effectively across multiple functional areas. -Ability to work non-standard schedules as business needs require. -Regular and predictable on-site attendance. Schedule: Monday - Friday 10:30am - 7pm 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 . All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. PI88104690b0d8-38003-41048496
