Quality Engineer II

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

Job Title: Quality Engineer II

Location: San Diego, CA

Duration: 06 Months

Job Summary:

The Quality Engineer II will develop and maintain quality engineering methodologies and provide quality engineering support across new product development, manufacturing, and quality system activities.

Key Responsibilities:

• Develop and implement effective process control systems for product development, qualification, and manufacturing.
• Lead quality assurance, process control, and CAPA activities to meet internal and regulatory requirements.
• Identify, investigate, and resolve quality issues using structured problem-solving methodologies.
• Design and execute experiments for process optimization and continuous improvement.
• Develop experiment protocols, plans, reports, and supporting documentation.
• Monitor and control Critical-to-Quality (CTQ) parameters and specifications.
• Apply Lean Manufacturing and Six Sigma methodologies to improve product and process performance.
• Lead investigations and corrective actions related to product and process nonconformances.
• Participate in cross-functional teams and provide Quality Engineering support for projects and product development.
• Complete and maintain product and process risk assessments.
• Support product verification and validation activities in collaboration with Design Engineering.
• Work with Microbiology teams to support environmental monitoring and microbiological requirements.
• Support Quality Management System (QMS), Environmental Management System (EMS), and other applicable regulatory requirements.
• Ensure compliance with FDA, GMP, ISO 13485, ISO 14971, and applicable quality and regulatory standards.

Qualifications:

• Bachelor's degree in Engineering, Technical field, or equivalent combination of education and experience.
• Master's degree preferred.
• 2 5 years of Quality Engineering or related engineering experience.
• Experience with quality tools, methodologies, and process improvement techniques.
• Working knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with CAPA, nonconformance investigations, process controls, and risk management.
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Strong statistical and data analysis skills.
• Strong technical documentation and report-writing skills.
• Excellent verbal and written communication skills.
• Strong project management, leadership, organizational, and problem-solving abilities.
• Ability to work effectively in cross-functional teams and a fast-paced environment.
• Strong attention to detail with the ability to manage multiple priorities and meet deadlines.
• Medical device industry experience preferred.
• ASQ CQE or related quality certification preferred.