Quality Engineer II – Process Excellence & Compliance (Med Tech)

Intellectt INC; San Diego (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

Intellectt INC in San Diego, CA is seeking a Quality Engineer II to develop and maintain quality engineering methodologies across new product development, manufacturing, and quality system activities.

The role focuses on process control, CAPA, risk assessment, and continuous improvement using Lean Six Sigma, with collaboration across Design Engineering, Microbiology, and QA teams. This is a 6-month contract position on-site in San Diego.

Qualifications

• Bachelor's degree in Engineering or technical field.
• Master's degree is preferred.
• 2–5 years of Quality Engineering experience.
• Working knowledge of FDA regulations, GMP, ISO 13485, ISO 14971.
• Experience with CAPA, nonconformance investigations, and risk management.
• Lean Six Sigma methodologies experience.

Responsibilities

• Develop and implement process control systems for product development and manufacturing.
• Lead QA, process control, and CAPA activities to meet requirements.
• Identify, investigate, and resolve quality issues using structured problem solving.
• Design and execute experiments for process optimization and improvement.
• Develop protocols, plans, and reports supporting QA activities.
• Monitor CTQ parameters and specifications.
• Apply Lean and Six Sigma to improve performance.
• Lead investigations and corrective actions for nonconformances.
• Support QA, EMS, and QMS regulatory requirements.
• Collaborate with cross-functional teams across projects.

Skills

Quality Engineering

FDA Regulations

CAPA

Lean Six Sigma

Statistics

Documentation

Cross-functional Teamwork

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

Intellectt INC in San Diego, CA is seeking a Quality Engineer II to develop and maintain quality engineering methodologies across new product development, manufacturing, and quality system activities.

The role focuses on process control, CAPA, risk assessment, and continuous improvement using Lean Six Sigma, with collaboration across Design Engineering, Microbiology, and QA teams. This is a 6-month contract position on-site in San Diego.