Quality Engineer

Intellectt Inc; San Diego (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Intellectt Inc is seeking a Quality Engineer II in San Diego to provide quality engineering support across new product development, manufacturing, and process improvement. The role requires hands-on experience with quality tools, medical device regulations, CAPA, risk management, and continuous improvement.

You will lead CAPA investigations, design experiments, monitor CTQ, and collaborate with Engineering, Manufacturing, Microbiology, and regulatory teams to ensure QMS compliance and product

Qualifications

• Bachelor’s degree in Engineering required; Master’s preferred.
• 2–7 years engineering experience with quality tools.
• Strong knowledge of FDA, GMP, ISO 13485, ISO 14971.
• Experience with CAPA, RCA, risk analysis, and nonconformance management.
• Experience with Lean/Six Sigma and statistical/data analysis.
• Strong communication, project management, and cross-functional leadership.
• ASQ CQE or similar certification preferred.

Responsibilities

• Develop and maintain process controls for development, qualification, and manufacturing.
• Lead CAPA, nonconformance investigations, root cause analysis, and corrective actions.
• Apply systematic problem-solving and quality engineering methodologies.
• Design and conduct DOE/experiments for process optimization.
• Monitor CTQ parameters and process performance.
• Drive Lean/Six Sigma and process improvement initiatives.
• Lead risk analysis and support product V&V with Design Engineering.
• Develop protocols, reports, and quality documentation.
• Collaborate cross-functionally with Engineering, Manufacturing, Microbiology, and others.
• Support QMS, EMS, FDA, and other regulatory requirements.

Skills

CAPA

RCA

Risk analysis

DOE

Process controls

Nonconformance management

Lean Six Sigma

Statistical analysis

Cross-functional leadership

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Job description

We are seeking a Quality Engineer II to provide quality engineering support across new product development, manufacturing, and process improvement. The ideal candidate will have hands‑on experience with quality tools, medical device regulations, process controls, CAPA, risk management, and continuous improvement.

Key Responsibilities

• Develop and maintain process controls for product development, qualification, and manufacturing.
• Lead CAPA, nonconformance investigations, root cause analysis, and corrective actions.
• Apply systematic problem‑solving and quality engineering methodologies.
• Design and conduct DOE/experiments for process optimization.
• Monitor CTQ parameters and process performance.
• Drive Lean/Six Sigma and process improvement initiatives.
• Lead risk analysis and support product V&V with Design Engineering.
• Develop protocols, reports, and quality documentation.
• Collaborate cross‑functionally with Engineering, Manufacturing, Microbiology, and other teams.
• Support QMS, EMS, FDA, and other regulatory requirements.

Required Qualifications

• Bachelor’s degree in Engineering or a technical field; Master’s preferred.
• 2–7 years of engineering experience with demonstrated use of quality tools.
• Strong knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Experience with CAPA, RCA, risk analysis, process controls, and nonconformance management.
• Experience with Lean/Six Sigma and statistical/data analysis.
• Strong communication, project management, and cross‑functional leadership skills.
• ASQ CQE or similar certification preferred.

Why Join?

Opportunity to work in a fast‑paced, highly matrixed medical device environment, partnering with cross‑functional and geographically diverse teams to improve product quality and manufacturing processes.