Senior Software Quality Engineer – Medical Device (Onsite)

Abbott; California; Presencial; USD 90.000 - 180.000; Jornada completa

Descripción de la vacante

Abbott is hiring a Senior Software Quality Engineer in Sylmar, CA, onsite. You will ensure software quality, compliance with FDA Design Controls, IEC 62304, and ISO 14971 across the SDLC for cloud-based medical device applications and supporting infrastructure.

You will collaborate with Development, DevOps, Regulatory Affairs, Cybersecurity, and Product Management to deliver secure, reliable software that meets regulatory requirements and patient safety standards. Remote work is not indicated.

Formación

• Bachelor's degree in engineering or a technical field or equivalent experience.
• 7+ years of software quality engineering experience.
• Experience with medical device regulations and cybersecurity guidance.

Responsabilidades

• Support all phases of SDLC including requirements, architecture, verification, validation, release management, and post-market support.
• Lead quality/compliance assessments for software defects and product issues and drive CAPAs.
• Ensure compliance with FDA regulations, Design Controls, CSA and cybersecurity standards; provide objective evidence during audits.

Conocimientos

Software Quality Engineering

Regulatory compliance

Risk management

Educación

Bachelor's Degree in Engineering/Technical Field

Herramientas

IEC 62304

ISO 14971

FDA Design Controls

CSA (Cybersecurity)

IEEE 1012

Descripción del empleo

Abbott is hiring a Senior Software Quality Engineer in Sylmar, CA, onsite. You will ensure software quality, compliance with FDA Design Controls, IEC 62304, and ISO 14971 across the SDLC for cloud-based medical device applications and supporting infrastructure.

You will collaborate with Development, DevOps, Regulatory Affairs, Cybersecurity, and Product Management to deliver secure, reliable software that meets regulatory requirements and patient safety standards. Remote work is not indicated.