Quality Specialist II

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: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition : 12095

Position Summary: The Quality Specialist II provides oversight of the Quality System to ensure compliance with regulatory standards and internal procedures. This role supports product quality and safety by reviewing documentation, data, and processes related to manufacturing, testing, and distribution, while driving adherence to industry regulations and continuous improvement.

• Provide quality oversight of the Quality System, including review of SOPs, protocols, reports, and manufacturing records.
• Perform timely review of data and documentation supporting batch release.
• Ensure compliance with FDA, ICH, and internal quality standards.
• Review records to ensure data integrity and accuracy.
• Support and approve investigations, including review of reports.
• Oversee equipment and software qualification, calibration, and validation activities.
• Collaborate with Corporate Quality to implement standardized processes and ensure compliance.
• Perform additional duties as assigned.

• Bachelor’s degree or equivalent combination of education and experience required.
• A minimum of 6 years of experience in a regulated industry.
• Strong knowledge of quality systems, regulatory requirements, and data integrity principles.
• Excellent problem‑solving, organizational, and communication skills.
• Ability to work independently with general supervision and manage multiple priorities.
• Relevant industry certification preferred.

• Primarily office‑based with occasional exposure to manufacturing environments.
• Light physical activity (sitting, standing, and occasional lifting up to 20 lbs).
• Moderate noise level.

Salary Range: $96,000 - $118,000 annually

Benefits include healthcare, a 401(k) plan, and tuition reimbursement.

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.

Equal employment opportunity, including veterans and individuals with disabilities.