Overview

B. Braun Medical, Inc.Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Monday, Wednesday, Tuesday, Friday, ThursdayShift: 5X8Relocation Available: NoRequisition ID: 12925B. 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 The Quality Specialist I provides hands-on quality support to manufacturing operations, ensuring products meet regulatory, safety, and quality standards. This role is responsible for reviewing documentation, supporting investigations, and maintaining compliance with internal quality systems and industry requirements. Key Responsibilities Review SOPs, protocols, reports, and batch records to support manufacturing and product releaseReview data (including metadata) to ensure accuracy, completeness, and data integritySupport deviations, investigations, and CAPAs, including review of reportsEnsure compliance with FDA, ICH, and internal quality standardsProvide oversight for equipment and software qualification, validation, and calibration activitiesPartner with quality and cross-functional teams to maintain compliance and standardized processes Qualifications Bachelor's degree or equivalent experience in a related field4+ years of experience in quality, manufacturing, or a regulated environmentUnderstanding of GMP/regulatory requirements and data integrity principles preferredStrong attention to detail and problem-solving skillsAbility to work independently and manage priorities Work Environment Primarily office-based with some time in a manufacturing environment Moderate noise levels in production areasRegular sitting, standing, and use of handsAbility to lift up to 20 lbs occasionally Schedule: Onsite M-F 8am to 5pmPay Rate- $90,000- $107,000 annually 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 .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 Dis