Senior Quality Engineer - Medical Devices Leader

B. Braun Medical Inc. (US); Carrollton (TX); Sur place; USD 105 000 - 115 000; Plein temps

Avantages offerts par ce poste

Healthcare

401(k) plan

Tuition reimbursement

Résumé du poste

B. Braun Medical Inc. is seeking a Senior Quality Engineer in Carrollton, TX to support and continuously improve our Quality Management System (QMS).

You will partner with cross-functional teams to ensure compliance, drive quality excellence, and lead process improvement initiatives that support safe and effective products. The role requires 6+ years of quality engineering experience in a regulated manufacturing environment, medical device industry background, and ASQ CQE/CQA or equivalent

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: QMS, CAPA, Root Cause Analysis, Change Control, Validation, Internal Auditing, Complaint Handling.

Responsabilités

• 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.

Connaissances

QMS

CAPA

Root Cause Analysis

Change Control

Validation

Internal Auditing

Complaint Handling

Formation

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

Master's degree

Outils

SAP

Description du poste

B. Braun Medical Inc. is seeking a Senior Quality Engineer in Carrollton, TX to support and continuously improve our Quality Management System (QMS).

You will partner with cross-functional teams to ensure compliance, drive quality excellence, and lead process improvement initiatives that support safe and effective products. The role requires 6+ years of quality engineering experience in a regulated manufacturing environment, medical device industry background, and ASQ CQE/CQA or equivalent