Senior Development Quality Engineer – Medical Devices

Abbott Laboratories; California, Northern (MO, KY); Hybrid; USD 90,000 - 180,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefit

Wellness program

Job summary

Abbott Laboratories in Sylmar, CA is seeking a Sr. Development Quality Engineer to develop and maintain quality engineering methodologies across new product development, design verification and validation, and manufacturing support.

Responsibilities include leading process control, quality investigations, risk analysis, and compliance with FDA, ISO 13485, and ISO 14971. You will mentor teams, drive Six Sigma and Lean initiatives, and ensure robust design controls throughout product lifecycle.

Qualifications

• Bachelor's degree in engineering or a technical field.
• Minimum 5 years of quality, design quality, reliability, electrical engineering, or related medical device experience.
• Knowledge of FDA, GMP, ISO 13485, and ISO 14971, design controls, and risk management principles.
• Solid communication and interpersonal skills.
• Experience with design verification/validation activities and regulatory testing.

Responsibilities

• Identify and implement process control systems for development, verification, validation, and manufacturing.
• Lead, coach, and mentor personnel.
• Develop and execute streamlined business systems to resolve design and quality issues.
• Lead risk analysis and ensure verification evidence aligns with risks.
• Lead product and process improvement initiatives (Six Sigma, Lean).

Skills

Quality engineering

Design quality

Reliability engineering

Electrical engineering

Quality tools

Supervisory experience

Education

Bachelors in Engineering

Edu/experience equivalence

Tools

Statistical analysis

Lean Six Sigma

Regulatory standards

Job description

Abbott Laboratories in Sylmar, CA is seeking a Sr. Development Quality Engineer to develop and maintain quality engineering methodologies across new product development, design verification and validation, and manufacturing support.

Responsibilities include leading process control, quality investigations, risk analysis, and compliance with FDA, ISO 13485, and ISO 14971. You will mentor teams, drive Six Sigma and Lean initiatives, and ensure robust design controls throughout product lifecycle.