Quality Systems Engineer - ISO 13485, Data-Driven QA Austin

591x Varian Medical Systems, Inc.; États-Unis; Sur place; USD 96 000 - 133 000; Plein temps

Avantages offerts par ce poste

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Life Insurance

Disability Insurance

Parking/Transit

Paid Time Off

Sick Time

Résumé du poste

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Engineer in Austin, TX to support manufacturing operations, supplier quality and quality systems in an ISO 13485:2016 environment. You will drive CAPA, nonconformance resolution, and continuous improvement programs across cross‑functional teams.

The role emphasizes data‑driven decision making, problem‑solving, and implementation of scalable quality practices to ensure product quality and regulatory compliance.

Qualifications

• Bachelor’s degree in Industrial, Mechanical, Manufacturing, Quality, or related engineering discipline, with 2+ years of experience.
• Experience supporting manufacturing operations, establishing QMS, investigations and continuous improvement.
• Working knowledge of ISO 13485:2016 or similar QMS requirements.
• Experience with structured problem‑solving and root cause analysis.
• Strong analytical skills to interpret data and drive corrective actions.

Responsabilités

• Serve as a key quality engineering resource across quality systems and operational excellence initiatives.
• Define, implement, maintain, and improve quality system processes, procedures, work instructions, and other controlled documentation.
• Support manufacturing operations by ensuring products, processes, and quality controls meet specifications and regulatory requirements.
• Investigate and close nonconforming materials and processes, partnering with Operations and Engineering to drive resolution.
• Lead root cause investigations and CAPA activities using structured problem‑solving methodologies.
• Analyze quality system data to identify trends and drive data‑based improvements.
• Establish and report key quality performance indicators and metrics.
• Support new product introductions, manufacturing readiness, process changes, and validation.
• Participate in audits, management reviews, document control, and quality systems processes for compliance.
• Collaborate with cross‑functional teams to resolve quality issues and enhance customer satisfaction.
• Apply Lean, Six Sigma, SPC, and other continuous improvement tools to reduce variation and improve yield.

Connaissances

Quality engineering

ISO 13485

Root cause analysis

Data analysis

Lean Six Sigma

Formation

Bachelor’s degree in engineering

Outils

SAP

ERP systems

eQMS

Description du poste

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Engineer in Austin, TX to support manufacturing operations, supplier quality and quality systems in an ISO 13485:2016 environment. You will drive CAPA, nonconformance resolution, and continuous improvement programs across cross‑functional teams.

The role emphasizes data‑driven decision making, problem‑solving, and implementation of scalable quality practices to ensure product quality and regulatory compliance.