Quality Engineer II - External Quality

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

Position Summary:

Quality Engineer II (QE II), is responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs), Purchased Finished Goods (PFG) suppliers, and external service providers to ensure the consistent delivery of safe, effective, and compliant products. This role supports the execution of the external quality program, including daytoday quality operations, issue resolution, data review, risk management, and compliance activities within

B. Braun's external supply network.

The QE II partners closely with cross functional teams, CMO personnel, and PFG suppliers to support investigations, change controls, audits, quality agreements, data trending, field actions and continuous improvement initiatives. This role ensures that external partners operate in accordance with

B. Braun quality standards, internal procedures, and all applicable global regulatory requirements.

Success in this position requires strong technical knowledge, attention to detail, problem solving capability, and the ability to build and maintain strong supplier relationships and work effectively with external partners.

Essential Duties & Responsibilities

• Support routine quality oversight of CMOs, PFG suppliers, and external service providers to ensure compliance with regulatory requirements and internal quality standards.
• Monitor CMO/PFG quality performance through data review, quality metrics, trending, and escalation of concerns.
• Review and support investigations for deviations, nonconformances, complaints, and supplier quality issues; ensure effective rootcause analysis and CAPA implementation.
• Support change control activities related to external manufacturing, packaging, testing, risk-based quality activities and supply chain operations.
• Assist with internal and external audit preparation, audit participation, and followup actions for CMOs and PFG suppliers.
• Review and approve supplier or CMO documentation including deviations, CAPAs, protocols, reports, and validation documents, as applicable. Maintain accurate records and ensure compliance with documentation and data integrity requirements.
• Support continuous improvement initiatives with CMOs and PFG suppliers to elevate product and process quality, reduce risk, and increase operational efficiency.
• Partner with internal teams (Quality, Regulatory, Supply Chain, R&D, Operations, etc.) to support new product introductions, technology transfers, and lifecycle management activities involving external partners.
• Assist in the development, maintenance, and execution of quality agreements and supplier quality plans.
• Conducts root cause analysis for defects, non-conformities or other quality failures.
• May be responsible for ensuring compliance with formal external quality standards.

Knowledge & Skills

• Working knowledge of cGMPs, ISO standards, and global regulatory expectations.
• Strong analytical and problem solving skills, including rootcause analysis tools and CAPA methodologies.
• Ability to interpret technical documentation, quality records, and regulatory requirements.
• Effective communication skills and ability to interact collaboratively with external partners.
• Strong attention to detail and ability to manage multiple priorities in a fastpaced environment.
• Requires full working knowledge of professional field and industry.
• Influences the development of and drives the application of principles, theories, concepts.

Qualifications:
Education & Experience

• Bachelor's degree in Engineering, Life Sciences, or related technical field required.
• 5+ years of experience in Quality Assurance, Quality Engineering, or manufacturing within pharmaceutical, medical device, combination product, or related regulated industries.
• Experience working with Contract Manufacturing Organization or suppliers preferred.

Physical &…