Senior Quality Engineer - MedTech Quality Leader

B. Braun Group; Carrollton (TX); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Tuition reimbursement

Job summary

B. Braun US Device Manufacturing LLC in Carrollton, TX, is seeking a Senior Quality Engineer with medical device industry experience to strengthen our Quality Management System and drive continuous improvement across cross-functional teams.

You will lead CAPA investigations, audits, and change control, ensure FDA and ISO 13485 compliance, and partner with Engineering and Manufacturing to deliver safe, high-quality medical products.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or 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).

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

QMS knowledge

CAPA investigations

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 with medical device industry experience to strengthen our Quality Management System and drive continuous improvement across cross-functional teams.

You will lead CAPA investigations, audits, and change control, ensure FDA and ISO 13485 compliance, and partner with Engineering and Manufacturing to deliver safe, high-quality medical products.