Senior Development Quality Engineer - Medical Devices

Regulatory Jobs; Los Angeles (CA); In loco; USD 90.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Free medical coverage (HIP PPO)

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Great place to work

Descrizione del lavoro

Abbott is seeking a Senior Development Quality Engineer in the United States (Sylmar area). The role protects patient safety by ensuring products meet quality standards and collaborates across functions to align with business needs.

The ideal candidate has 5+ years in medical device quality engineering and understands FDA and ISO 13485 frameworks. The position requires leadership in Design Control, risk management, and verification/validation activities, with opportunities to mentor others and

Competenze

• Minimum 5 years in quality engineering within medical devices.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Strong communication and leadership for cross-functional teams.
• ASQ CQE or DfSS training is a plus.

Mansioni

• Lead on-time completion of Design Control Deliverables.
• Develop quality plans for internal development and OEM projects.
• Plan and execute Design Verification and Validation activities.
• Lead risk management from concept to commercialization.
• Ensure DHF content integrity and regulatory compliance.
• Support manufacturing process development and product changes.
• Coordinate internal/external audit responses and CAPA.
• Develop and mentor team members.

Conoscenze

Quality engineering

FDA knowledge

GMP knowledge

ISO 13485 knowledge

Project management

Leadership

Formazione

Bachelor's degree in Engineering or Technical Field

Master's degree - Preferred

Strumenti

Statistical analysis

Descrizione del lavoro

Abbott is seeking a Senior Development Quality Engineer in the United States (Sylmar area). The role protects patient safety by ensuring products meet quality standards and collaborates across functions to align with business needs.

The ideal candidate has 5+ years in medical device quality engineering and understands FDA and ISO 13485 frameworks. The position requires leadership in Design Control, risk management, and verification/validation activities, with opportunities to mentor others and