Senior Design QA Lead - Medical Devices, Global Compliance

Regulatory Jobs; 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 time

Job summary

Siemens Healthineers in Austin, TX is seeking a Design Quality Assurance Specialist to oversee design and development, ensuring compliance with 21 CFR 820, EU MDR, and ISO 13485. You will collaborate with design and engineering teams to apply product realization processes and maintain product quality throughout the lifecycle.

You will support audits, work with North America and overseas, and contribute to risk management, data analysis, and CAPA activities in a global, fast-paced environment.

Qualifications

• B.S. degree in engineering or related field with 7+ years of experience in medical devices or pharmaceutical industry, or M.S. with 4+ years of related experience.
• Experience in product development or design quality assurance in medical devices or regulated industry.
• Ability to work with international standards and regulations applicable to medical devices.
• ASQ Certified Quality Engineer or Certified Reliability Engineer (preferred)

Responsibilities

• Ensure compliance requirements are met according to applicable regulations and standards (21CFR 820, EU MDR 2017/745, ISO 13485).
• Collaborate with design and engineering teams to apply product realization processes and ensure compliance.
• Review design and development documentation for adequacy and alignment with global processes.
• Support verification and validation activities and document results.
• Engage in design and development to support risk management and final production controls.
• Define and analyze statistical data.
• Support root cause analysis and corrective actions implementation.

Skills

Regulatory awareness

Quality mindset

Analytical thinking

Communication

Education

B.S. in Engineering or related field +7+ years OR M.S. +4+ years

Tools

ASQ Certification

Regulatory knowledge

Job description

Siemens Healthineers in Austin, TX is seeking a Design Quality Assurance Specialist to oversee design and development, ensuring compliance with 21 CFR 820, EU MDR, and ISO 13485. You will collaborate with design and engineering teams to apply product realization processes and maintain product quality throughout the lifecycle.

You will support audits, work with North America and overseas, and contribute to risk management, data analysis, and CAPA activities in a global, fast-paced environment.