Senior Quality Engineer: Lead Process Improvement

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

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott Laboratories in Sylmar, CA seeks a Quality Engineer to develop and maintain quality engineering methodologies across new product development, manufacturing, and service support. You will identify control systems and lead teams to ensure products meet internal and external requirements.

The role requires 5+ years of experience, knowledge of FDA GMP ISO standards, Six Sigma/Lean, and strong communication and leadership; Abbott offers comprehensive health coverage, retirement savings,

Qualifications

• Bachelor’s Degree in Engineering or a related technical field.
• Minimum 5 years of experience in quality engineering or a similar role.
• Experience with FDA, GMP, ISO 13485, and ISO 14971.
• Strong leadership, communication, and project management skills.
• Experience with Six Sigma and Lean Manufacturing methodologies.
• Prior medical device experience preferred.

Responsibilities

• Identify and implement process control systems for development and manufacturing.
• Lead and mentor staff and cross-functional teams.
• Develop streamlined systems to identify and resolve quality issues.
• Apply systematic problem-solving to prioritize and resolve quality issues.
• Design experiments for process optimization and document results.
• Lead risk analysis and participate in product verification and validation.
• Ensure compliance with QMS and EMS regulatory requirements.

Skills

Quality engineering

Leadership

Project management

Statistical analysis

Six Sigma

Lean Manufacturing

FDA GMP ISO 13485 ISO 14971

Communication skills

Team mentoring

Education

Bachelor's Degree in Engineering or technical field

Tools

Statistical analysis software

Job description

Abbott Laboratories in Sylmar, CA seeks a Quality Engineer to develop and maintain quality engineering methodologies across new product development, manufacturing, and service support. You will identify control systems and lead teams to ensure products meet internal and external requirements.

The role requires 5+ years of experience, knowledge of FDA GMP ISO standards, Six Sigma/Lean, and strong communication and leadership; Abbott offers comprehensive health coverage, retirement savings,