Senior Quality Engineer - MedTech Quality & Compliance Lead

B. Braun US Device Manufacturing LLC; Carrollton (TX); On-site; USD 105,000 - 115,000; Full time

Job summary

B. Braun US Device Manufacturing LLC in Carrollton, TX is seeking a Senior Quality Engineer to strengthen the Quality Management System and drive process improvements.

The role partners with cross-functional teams to ensure regulatory compliance and to advance product quality and patient safety. Eligible candidates will have a bachelor’s degree in a related field, 6+ years in quality engineering within a regulated manufacturing environment, and professional ASQ CQE/CQA certification or

Qualifications

• 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.

Responsibilities

• Lead and support quality system activities, including: Nonconformances, CAPA investigations, Complaint investigations and trend analysis, Change control, Validation activities, Quality inspections, 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.

Skills

Quality Management Systems (QMS)

CAPA

Root Cause Analysis

Change Control

Validation

Internal Auditing

Complaint Handling

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related field

Tools

SAP

Job description

B. Braun US Device Manufacturing LLC in Carrollton, TX is seeking a Senior Quality Engineer to strengthen the Quality Management System and drive process improvements.

The role partners with cross-functional teams to ensure regulatory compliance and to advance product quality and patient safety. Eligible candidates will have a bachelor’s degree in a related field, 6+ years in quality engineering within a regulated manufacturing environment, and professional ASQ CQE/CQA certification or