Senior Design QA Specialist – Medical Devices

Siemens Healthineers AG; Austin (TX); On-site; USD 112,000 - 155,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is seeking a Design Quality Assurance Specialist in Austin, TX. You will ensure product realization processes meet regulatory requirements and collaborate with design and engineering to maintain quality across the full lifecycle.

The role requires extensive experience in medical device QA, knowledge of 21CFR820, EU MDR, ISO 13485, and a strong statistical background.

Qualifications

• Requires 7+ years of experience in medical device QA or regulated industry.
• Experience in product development or design quality assurance for medical devices.
• Ability to work with international medical device standards/regulations.
• ASQ certifications are preferred.
• Knowledge of statistics, process control, and DOE.
• Understanding of chemical manufacturing and basic lab skills.
• Experience in controlled environments and cleanrooms.

Responsibilities

• Ensure compliance with 21CFR Part 820, EU MDR 2017/745, ISO 13485 and company quality systems.
• Collaborate with design/engineering to ensure product realization processes are appropriate and compliant.
• Review design and development documentation for adequacy and consistency with global processes.
• Support verification/validation with proper documentation.
• Involve in design phases to support risk management and production-stage controls.
• Define and analyze statistical data.
• Assist engineering with root cause analysis and corrective actions.

Skills

Regulated industry QA

Statistical methods

Root cause analysis

Cleanrooms experience

Chemical manufacturing knowledge

Controlled environments

Education

B.S. degree in a related field (Mechanical, Electrical, Chemical, or Chemistry)

M.S. degree with 4+ years of related experience

Tools

ASQ Certified Quality Engineer

Certified Reliability Engineer

Job description

Varian Medical Systems, a Siemens Healthineers company, is seeking a Design Quality Assurance Specialist in Austin, TX. You will ensure product realization processes meet regulatory requirements and collaborate with design and engineering to maintain quality across the full lifecycle.

The role requires extensive experience in medical device QA, knowledge of 21CFR820, EU MDR, ISO 13485, and a strong statistical background.