Quality Specialist I

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. 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.

Responsibilities

• Review SOPs, protocols, reports, and batch records to support manufacturing and product release
• Review data (including metadata) to ensure accuracy, completeness, and data integrity
• Support deviations, investigations, and CAPAs, including review of reports
• Ensure compliance with FDA, ICH, and internal quality standards
• Provide oversight for equipment and software qualification, validation, and calibration activities
• Partner with quality and cross-functional teams to maintain compliance and standardized processes

Requirements

• Bachelor’s degree or equivalent experience in a related field
• 4+ years of experience in quality, manufacturing, or a regulated environment
• 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

Schedule

Onsite Monday through Friday, 8:00 AM to 5:00 PM

Pay

$90,000 - $107,000 annually. The targeted range for this role takes into account factors such as skill sets, experience and training, licensure and certifications, and other business and organizational needs.

Benefits

• Healthcare
• 401(k) plan
• Tuition reimbursement