Sr. Quality Engineer

About the role

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. The position is located in Carrollton, TX. We are seeking a Senior Quality Engineer with medical device industry experience to support and continuously improve our Quality Management System (QMS). In this role, you will partner with cross-functional teams to ensure compliance, drive quality excellence, and lead process improvement initiatives that support safe and effective products.

Responsibilities

• Lead and support quality system activities, including: nonconformances, CAPA investigations, complaint investigations and trend analysis, change control, validation activities, quality inspections, Material Review Board (MRB) activities, internal audits
• Conduct root cause investigations and implement effective corrective actions.
• Collaborate with Engineering, Manufacturing, and other teams to identify and mitigate quality risks.
• Ensure compliance with FDA regulations, ISO 13485, and internal quality standards.
• Audit processes, suppliers, and materials to ensure quality requirements are met.
• Drive continuous improvement and quality enhancement projects.
• Analyze quality data and recommend process improvements.

Requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
• 6+ years of Quality Engineering experience in a regulated manufacturing environment.
• Medical Device industry experience required.
• Professional quality certification (ASQ CQE, CQA, or equivalent).

Skills

• Strong knowledge of Quality Management Systems (QMS), CAPA, Root Cause Analysis, Change Control, Validation, Internal Auditing, Complaint Handling.
• Preferred: Master's degree.
• Preferred: Experience with SAP.
• Preferred: Experience leading projects, teams, or continuous improvement initiatives.
• Preferred: Knowledge of Lean Manufacturing or Six Sigma methodologies.
• Preferred: Experience supporting regulatory audits and inspections.

Benefits

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.

Pay

Salary Range: $105,300 - $115,300

Schedule

Ability to work non-standard hours as needed to support business objectives.