Senior Quality Engineer - Med Device QMS & CAPA Leader

B. Braun; Carrollton (TX); Presencial; USD 105 000 - 115 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Healthcare benefits

401(k)

Tuition reimbursement

Resumo da oferta

B. Braun US Device Manufacturing LLC is seeking a Senior Quality Engineer to support and continuously improve the Quality Management System (QMS). You will collaborate with cross-functional teams to ensure regulatory compliance and drive quality excellence in medical device manufacturing.

The role requires 6+ years in quality engineering in a regulated environment, ASQ CQE/CQA, and hands-on CAPA, root cause analysis, change control, and validation experience; familiarity with SAP is a plus.

Qualificações

• Bachelor's degree required 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).
• Strong knowledge of QMS, CAPA, Root Cause Analysis, Change Control, Validation, Internal Auditing, and Complaint Handling.

Responsabilidades

• Lead and support quality system activities including nonconformances, CAPA investigations, complaint investigations and trend analysis, change control, validation activities, quality inspections, MRB activities, and 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.

Conhecimentos

QMS

CAPA

Root cause analysis

Change control

Validation

Internal auditing

Complaint handling

Formação académica

Bachelor's degree in Engineering/Quality/Life Sciences

Ferramentas

SAP

Descrição da oferta de emprego

B. Braun US Device Manufacturing LLC is seeking a Senior Quality Engineer to support and continuously improve the Quality Management System (QMS). You will collaborate with cross-functional teams to ensure regulatory compliance and drive quality excellence in medical device manufacturing.

The role requires 6+ years in quality engineering in a regulated environment, ASQ CQE/CQA, and hands-on CAPA, root cause analysis, change control, and validation experience; familiarity with SAP is a plus.