Quality Systems Engineer - Healthcare Manufacturing

Siemens Healthineers AG; Austin (TX); On-site; USD 96,000 - 133,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Job summary

Siemens Healthineers is hiring a Quality Engineer in Austin, TX to support manufacturing operations under an ISO 13485:2016 compliant environment. You will improve quality systems, lead CAPAs, and drive investigations with cross-functional teams.

The role emphasizes data-driven problem solving, SPC methods, and collaboration with Operations, Regulatory, and Supply Chain to maintain product quality and regulatory compliance.

Qualifications

• Bachelor's degree in an engineering discipline with 2+ years in quality/manufacturing/process engineering.
• Experience supporting manufacturing operations, establishing QMS, investigations, and continuous improvement.

Responsibilities

• Define, implement, and improve quality system processes and controlled documentation to support ISO 13485:2016 compliance.
• Investigate nonconforming materials and drive timely CAPA closures with cross-functional teams.
• Lead root cause investigations and containment actions using structured problem-solving methods.
• Analyze quality data to identify trends and drive data-based improvements.
• Support new product introductions, process validation, and readiness activities.
• Participate in internal audits, management reviews, and document control processes.

Skills

ISO 13485

Root Cause Analysis

CAPA

Lean Six Sigma

Six Sigma Green Belt

CQE

Data-driven decision making

Cross-functional collaboration

Education

Bachelor's degree in Industrial/Mechanical/Manufacturing/Quality

Tools

SAP

ERP systems

eQMS

SPC / Statistical tools

Job description

Siemens Healthineers is hiring a Quality Engineer in Austin, TX to support manufacturing operations under an ISO 13485:2016 compliant environment. You will improve quality systems, lead CAPAs, and drive investigations with cross-functional teams.

The role emphasizes data-driven problem solving, SPC methods, and collaboration with Operations, Regulatory, and Supply Chain to maintain product quality and regulatory compliance.