Senior Medical Device Quality Engineer

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

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott is seeking a Senior Development Quality Engineer to assure new or modified products meet quality standards and regulatory requirements. You will protect patient safety while partnering across functions to deliver compliant, high-quality medical devices.

Responsibilities include leading Design Verification/Validation, risk management, DHF integrity, and supplier qualifications, with travel up to 10%. Abbott offers strong benefits and a path for growth within a global healthcare leader.

Qualifications

• Bachelor's degree in Engineering or technical field is required.
• Minimum 5 years of quality engineering experience.
• Knowledge of FDA, GMP, and ISO 13485 regulatory requirements.
• Strong communication and leadership abilities across teams.
• ASQ CQE certification preferred.
• Ability to travel up to 10%, including international.

Responsibilities

• Create and ensure on-time execution of Quality Plans for development, OEM, CPDP, and design change projects.
• Lead Design Verification and Validation planning and execution with root-cause analysis.
• Lead Risk Management from concept through commercialization.
• Lead design test method development and validation activities.
• Ensure DHF content completion and regulatory compliance.
• Support manufacturing process development and qualification for new products.
• Coordinate internal and external audit responses and on-time product re-certifications.
• Develop and mentor other team members.
• Support FDA, GMP, ISO regulatory requirements and company programs.

Skills

Quality engineering

FDA/GMP/ISO13485

Statistical analysis

Project management

Cross-functional leadership

Communication skills

Education

Bachelor's degree in Engineering or Technical Field

Master's degree

Job description

Abbott is seeking a Senior Development Quality Engineer to assure new or modified products meet quality standards and regulatory requirements. You will protect patient safety while partnering across functions to deliver compliant, high-quality medical devices.

Responsibilities include leading Design Verification/Validation, risk management, DHF integrity, and supplier qualifications, with travel up to 10%. Abbott offers strong benefits and a path for growth within a global healthcare leader.