Quality Engineer II: Process Control & CAPA Lead

Abbott; San Diego (CA); On-site; USD 85,000 - 105,000; Part time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

401(k)

Job summary

Abbott in San Diego, CA is seeking a Quality Engineer II for a 7-month, 100% onsite assignment. Shifts are 3PM to 11:30PM. The role focuses on establishing effective process controls, CAPA systems, and quality assurance across development and manufacturing.

You will lead Six Sigma/Lean improvements, risk analysis, and cross-functional collaboration with Design, Microbiology, and QA teams. The position requires 2–5 years of engineering experience with strong knowledge of FDA regulations and ISO

Qualifications

• Bachelor's degree in Engineering or technical field or equivalent experience.
• Master's degree preferred.
• 2-5 years engineering experience with quality tools/methodologies.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971 is required or preferred.

Responsibilities

• Identify and implement process control systems for development, qualification, and manufacturing of products.
• Lead assurance, process controls, CAPA systems.
• Develop and execute streamlined business systems to identify and resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Document experiment plans, protocols, and results.
• Lead CTQ monitoring and product/process improvements (Six Sigma/Lean).
• Investigate, resolve, and prevent non-conformances.
• Collaborate with design engineering and microbiology on product verification/validation.

Skills

Quality tools / methodologies

Statistical data analysis

Project management

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering or technical field

Master's degree

Job description

Abbott in San Diego, CA is seeking a Quality Engineer II for a 7-month, 100% onsite assignment. Shifts are 3PM to 11:30PM. The role focuses on establishing effective process controls, CAPA systems, and quality assurance across development and manufacturing.

You will lead Six Sigma/Lean improvements, risk analysis, and cross-functional collaboration with Design, Microbiology, and QA teams. The position requires 2–5 years of engineering experience with strong knowledge of FDA regulations and ISO