Senior Quality Engineer — Lead Quality & Process Improvement

Regulatory Jobs; California; Presencial; USD 90.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free medical coverage for employees

Excellent retirement plan with high-em

Tuition reimbursement

FreeU education benefit

Descripción de la vacante

Abbott is a global healthcare leader seeking a Quality Engineer to develop and maintain quality engineering methodologies across new product development, manufacturing, or service support. You will implement process controls, lead teams, and drive continuous improvement in a regulated medical device environment.

The role emphasizes Six Sigma and Lean methods, documentation, risk assessment, and collaboration with design, microbiology, and manufacturing to ensure product quality and regulatory

Formación

• Bachelor's degree in an Engineering or Technical field, or equivalent experience.
• Minimum 5 years in quality engineering experience.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971.
• ASQ CQE or similar certification preferred.
• Strong communication and leadership skills.
• Experience with Six Sigma and Lean Manufacturing.
• Experience in regulated medical device environments.

Responsabilidades

• Identify and implement effective process control systems to support development, qualification, and manufacturing of products.
• Lead, coach, and mentor personnel.
• Develop and execute streamlined business systems to identify and resolve quality issues.
• Apply systematic problem-solving to quality issues.
• Design and conduct experiments for process optimization.
• Document experimental plans and results, including protocols and reports.
• Lead process control and monitoring of CTQ parameters.

Conocimientos

Quality engineering

Six Sigma

Lean Manufacturing

Project management

Leadership

Statistical analysis

Documentation

Educación

Bachelor's degree in Engineering or technical field

Herramientas

Quality tools

Descripción del empleo

Abbott is a global healthcare leader seeking a Quality Engineer to develop and maintain quality engineering methodologies across new product development, manufacturing, or service support. You will implement process controls, lead teams, and drive continuous improvement in a regulated medical device environment.

The role emphasizes Six Sigma and Lean methods, documentation, risk assessment, and collaboration with design, microbiology, and manufacturing to ensure product quality and regulatory