Onsite Senior Software Quality Engineer (Medical Devices)

Regulatory Jobs; Los Angeles (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Tuition reimbursement

Job summary

Abbott in Sylmar, CA is seeking a Software Quality Engineer responsible for quality, compliance, and design assurance of cloud-based medical device software.

You will work with Development, DevOps, Regulatory Affairs, and Cybersecurity to ensure secure, validated software that meets FDA Design Controls and industry standards.

Role requires 7+ years in software quality with IEC 62304, ISO 14971, ISO 13485 knowledge and some travel (up to 25%).

Qualifications

• Bachelor's degree in engineering or a technical field.
• 7+ years in Software Quality Engineering.
• Experience with medical device software standards and regulatory requirements.

Responsibilities

• Support SDLC activities with focus on quality, compliance, and design control.
• Lead risk management filings related to software and systems.
• Support audits, regulatory inspections, and CAPA processes.
• Collaborate with cross-functional teams to ensure compliant product releases.

Skills

Software Quality

Regulatory Compliance

Design Assurance

Data Analysis

Cross-functional Collaboration

Education

Bachelors Degree in Engineering

Tools

IEC 62304

ISO 14971

ISO 13485

FDA Design Controls

CSA (Cyber Software Assurance)

Job description

Abbott in Sylmar, CA is seeking a Software Quality Engineer responsible for quality, compliance, and design assurance of cloud-based medical device software.

You will work with Development, DevOps, Regulatory Affairs, and Cybersecurity to ensure secure, validated software that meets FDA Design Controls and industry standards.

Role requires 7+ years in software quality with IEC 62304, ISO 14971, ISO 13485 knowledge and some travel (up to 25%).