Senior Quality Engineer, Medical Devices CAPA & Compliance

RXinsider LTD.; Carrollton (TX); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Healthcare

401(k)

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Carrollton, TX is seeking a Senior Quality Engineer to lead quality system activities and investigations.

The role requires expertise in CAPA, root cause analysis, change control, and validation to ensure FDA and ISO 13485 compliance. Ideal candidates have 6+ years in quality engineering, medical device experience, and ASQ CQE/CQA or equivalent certification. The position involves collaboration with engineering, manufacturing, and suppliers to drive improvements and

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
• ASQ CQE, CQA, or equivalent professional certification preferred.
• 6+ years of Quality Engineering experience in a regulated manufacturing environment.
• Medical Device industry experience required.
• Strong knowledge of QMS, CAPA, Root Cause Analysis, Change Control, Validation, Internal Auditing, and Complaint Handling.

Responsibilities

• Lead and support quality system activities including Nonconformances, CAPA investigations, complaints 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.

Skills

Quality Management Systems

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 Medical Inc. in Carrollton, TX is seeking a Senior Quality Engineer to lead quality system activities and investigations.

The role requires expertise in CAPA, root cause analysis, change control, and validation to ensure FDA and ISO 13485 compliance. Ideal candidates have 6+ years in quality engineering, medical device experience, and ASQ CQE/CQA or equivalent certification. The position involves collaboration with engineering, manufacturing, and suppliers to drive improvements and