Senior Medical Device Software Quality Engineer

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

Job summary

Abbott in Sylmar, CA is seeking a Software Quality Engineer to ensure software applications and infrastructure for cloud-based medical devices meet regulatory and quality requirements. You will collaborate with Development, DevOps, Product, and Regulatory teams to deliver secure, compliant software solutions for patient care.

The role emphasizes SDLC support, risk management, audits, and continuous improvement in a highly matrixed environment.

Qualifications

• Minimum 7 years of Software Quality Engineering experience.
• Detailed knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA CSA, Medical Device Cybersecurity Guidance, Software Validation Principles, IEEE 1012.
• Advanced computer skills including statistical/data analysis and report writing.
• Advanced IT and data mining skills.
• ASQ CSQE certification desired.
• Ability to travel approximately 5-25%, including internationally.

Responsibilities

• Support all phases of the Software Development Lifecycle (SDLC) from requirements through post-market support.
• Review lifecycle deliverables and ensure alignment with Design Control requirements and risk management.
• Evaluate impact of software changes on requirements, testing, and regulatory compliance.
• Assist in maintaining risk management files for software and system risks.
• Lead quality and compliance assessments for software defects and product issues with proper risk evaluations and CAPAs.
• Evaluate verification/validation strategies and traceability to ensure compliant releases.
• Support internal and external audits and regulatory inspections with objective evidence.
• Drive continuous improvement and support investigations and CAPAs.
• Serve as software compliance and design assurance SME among cross-functional teams.
• Support Quality Management Systems and regulatory requirements.

Skills

Software quality engineering

Regulatory standards familiarity

Statistical analysis

Data mining

Report writing

Team collaboration

Travel readiness

Education

Bachelor's degree in Engineering or technical field

Equivalent combination of education and work experience

Tools

ASQ CSQE certification

Cybersecurity guidelines knowledge

Job description

Abbott in Sylmar, CA is seeking a Software Quality Engineer to ensure software applications and infrastructure for cloud-based medical devices meet regulatory and quality requirements. You will collaborate with Development, DevOps, Product, and Regulatory teams to deliver secure, compliant software solutions for patient care.

The role emphasizes SDLC support, risk management, audits, and continuous improvement in a highly matrixed environment.