Sr. Quality Engineer

B. Braun•Carrollton, TX

12d•Onsite

About The Position

B. Braun Medical Inc. is 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.

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).
Strong knowledge of: Quality Management Systems (QMS), CAPA, Root Cause Analysis, Change Control, Validation, Internal Auditing, Complaint Handling.

Nice To Haves

Master's degree.
Experience with SAP.
Experience leading projects, teams, or continuous improvement initiatives.
Knowledge of Lean Manufacturing or Six Sigma methodologies.
Experience supporting regulatory audits and inspections.

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.