Senior Development Quality Engineer - Medical Devices

Abbott; California; On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

HIP PPO medical plan

Tuition reimbursement

FreeU education benefit

Strong retirement savings plan

Job summary

Abbott is seeking a Senior Development Quality Engineer in Sylmar, CA to ensure new or modified medical devices meet quality and regulatory standards. You will lead design control deliverables, design verification/validation, risk management, and documentation to support commercialization and ongoing quality improvements.

The role requires 5+ years in quality engineering, strong communication, and cross-functional leadership. Travel and matrixed environment experience are a plus.

Qualifications

• Minimum 5 years of quality engineering experience.
• Knowledge of FDA, GMP, and ISO 13485.
• Strong communication and leadership skills.

Responsibilities

• Lead on-time completion of Design Control Deliverables.
• Plan and execute Design Verification and Validation.
• Lead Risk Management from concept to commercialization.
• Support audits and regulatory activities.
• Ensure DHF content integrity and regulatory compliance.
• Collaborate with manufacturing and supplier qualifications.

Skills

Quality tools

Cross-functional leadership

Project management

Communication

Education

Bachelor's degree in Engineering or Technical Field

Master's degree (preferred)

Job description

Abbott is seeking a Senior Development Quality Engineer in Sylmar, CA to ensure new or modified medical devices meet quality and regulatory standards. You will lead design control deliverables, design verification/validation, risk management, and documentation to support commercialization and ongoing quality improvements.

The role requires 5+ years in quality engineering, strong communication, and cross-functional leadership. Travel and matrixed environment experience are a plus.