Senior Medical Device Design QA Leader

Siemens Healthineers; 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

Long-term disability

Short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Varian Medical Systems, a Siemens Healthineers company in Austin, TX, is seeking a Design Quality Assurance Specialist. You will ensure design controls are in place and compliant across the product lifecycle, while supporting audits and collaborating with North American and international partners.

The role requires a strong background in medical device QA, knowledge of 21 CFR 820, EU MDR, ISO 13485, and statistics; experience in controlled environments and cleanrooms is preferred.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical engineering or related field; 7+ years in medical device or pharma QA
• MS degree with 4+ years acceptable
• Experience with design quality assurance and product development in regulated industry
• Familiarity with 21 CFR 820, EU MDR, ISO 13485 and company quality systems

Responsibilities

• Ensure compliance with applicable regulations and standards (21 CFR 820, EU MDR, ISO 13485)
• Collaborate with design and engineering to ensure product realization processes are compliant
• Review design and development documents for adequacy and alignment with processes
• Support verification/validation activities and documentation
• Engage in risk management from early design through production
• Collect and analyze statistical data for process control
• Assist engineering teams with root cause analysis and corrective actions

Skills

Regulatory compliance

QA in medical devices

Cross-functional collaboration

Statistical methods

Root cause analysis

Cleanroom experience

Clinical/regulated environment

Education

Bachelor/Master in Engineering or related field

Job description

Varian Medical Systems, a Siemens Healthineers company in Austin, TX, is seeking a Design Quality Assurance Specialist. You will ensure design controls are in place and compliant across the product lifecycle, while supporting audits and collaborating with North American and international partners.

The role requires a strong background in medical device QA, knowledge of 21 CFR 820, EU MDR, ISO 13485, and statistics; experience in controlled environments and cleanrooms is preferred.