Senior Software QA Engineer, Medical Devices & Cloud

Abbott; Los Angeles (CA); Presencial; USD 90.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free HIP PPO medical plan next year

Retirement savings plan with high-empr

Tuition reimbursement / FreeU

Descripción de la vacante

Abbott is seeking an onsite Software Quality Engineer in Sylmar, CA to ensure software quality, compliance, and design assurance for cloud-based medical device applications and supporting infrastructure. The role collaborates with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs to deliver secure, reliable software that meets regulatory requirements.

The position requires a Bachelor's degree in engineering, 7+ years of software quality

Formación

• Education: Bachelor’s Degree in Engineering or Technical Field or equivalent.
• Minimum 7 years of Software Quality Engineering experience.
• Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA CSA, Cybersecurity Guidance, IEEE 1012.

Responsabilidades

• Support all SDLC phases including requirements, architecture, implementation, verification, validation, release management, and post-market support.
• Review lifecycle deliverables and ensure alignment with Design Controls and risk management.
• Lead risk assessments and CAPAs related to software defects and regulatory compliance.
• Provide evidence for audits and regulatory inspections; support continuous improvement.

Conocimientos

IEC 62304

ISO 14971

ISO 13485

FDA Design Controls

FDA Computer Software Assurance

Medical Device Cybersecurity Guidance

Software Validation Principles

IEEE 1012

Statistical analysis

Report writing

Educación

Bachelor's Degree in Engineering or Technical Field

Herramientas

Statistical software

Descripción del empleo

Abbott is seeking an onsite Software Quality Engineer in Sylmar, CA to ensure software quality, compliance, and design assurance for cloud-based medical device applications and supporting infrastructure. The role collaborates with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs to deliver secure, reliable software that meets regulatory requirements.

The position requires a Bachelor's degree in engineering, 7+ years of software quality