Quality Investigator

Company: B. Braun US Pharmaceutical Manufacturing LLC

Job Posting Location: Irvine, California, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday

Shift: 5X8

Relocation Available: No

Requisition ID: 12932

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 Investigator is responsible for leading investigations related to non-conformances, deviations, complaints, and quality events to ensure compliance with regulatory requirements and internal quality standards. This role partners with Quality, Manufacturing, Engineering, and Regulatory teams to identify root causes, implement corrective actions, and drive continuous improvement.

Key Responsibilities

• Lead investigations of quality events, non-conformances, deviations, and product complaints
• Conduct root cause analyses and recommend corrective and preventive actions (CAPAs)
• Prepare investigation reports and present findings to Quality Management
• Manage quality records, investigations, and corrective actions through closure
• Review quality documentation to support product release and compliance requirements
• Support internal and external audits and continuous improvement initiatives
• Collaborate cross-functionally to resolve quality and process issues
• Perform trend analysis and product quality reviews as needed
• Maintain a basic understanding of applicable regulatory requirements and compliance standards

Qualifications

• Bachelor's degree required
• 2+ years of experience in Quality, Manufacturing, Engineering, or a regulated environment
• Knowledge of GMP, quality systems, investigations, and CAPA processes
• Strong analytical, problem-solving, and technical writing skills
• Experience in pharmaceutical, medical device, biotech, or other regulated industries preferred

Work Environment

• Office, laboratory, and manufacturing environment
• Ability to occasionally lift up to 20 pounds

This is an excellent opportunity for a quality professional looking to make an impact in a fast-paced, regulated manufacturing environment.

Salary Range- $71,169 - $89,000

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.