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. 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. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. To learn more about B. Braun Medical, visit www.bbraunusa.com

About the role

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.

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

Qualifications

• 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.

Benefits

• Healthcare
• 401(k) plan
• Tuition reimbursement

Pay

$90,000‑$107,000 annually

Schedule

Onsite M‑F 8am to 5pm