Quality Specialist I
B. Braun Medical Inc. (US) · Irvine, CA · 3 wk ago
On-siteQuality Assurance$90k–$107k/yrFull-time
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
- Complete batch record reviews (both electronic and paper) to support manufacturing operations and product release
- Review SOPs, protocols, reports, and batch records for accuracy and compliance
- Review data (including metadata) to ensure accuracy, completeness, and data integrity
- Support deviations (NCs), investigations, and CAPAs, including review of reports in systems such as TrackWise
- Ensure compliance with FDA, ICH, and internal quality standards
- Provide oversight for equipment and software qualification, validation, and calibration activities
- Utilize and maintain data within systems such as LIMS, ERP, and spreadsheets to support quality processes
- Partner with quality and cross-functional teams to maintain compliance and standardized processes
Qualifications
- Bachelor’s degree or equivalent experience in a related field
- 4+ years of experience in quality, manufacturing, or a regulated environment
- Experience with quality and business systems such as TrackWise (NCs), LIMS, ERP systems, and spreadsheets
- Understanding of GMP/regulatory requirements and data integrity principles preferred
- Strong attention to detail and problem-solving skills
- Ability to work independently and manage priorities
Work Environment
- Primarily office-based with some time in a manufacturing environment
- Moderate noise levels in production areas
- Regular sitting, standing, and use of hands
- Ability to lift up to 20 lbs occasionally
Pay Rate
The pay rate for this role is $90,000 - $107,000 annually.
Benefits
- Excellent benefits package including healthcare, a 401(k) plan, and tuition reimbursement
Company Information
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.