Quality Engineer - Medical Devices, Lean Six Sigma, Onsite

Agile Search Inc.; San Diego (CA); On-site; USD 85,000 - 130,000; Full time

Job summary

Agile Search is seeking a mid–senior Quality Engineer for an onsite role in San Diego (92121). You will support customer and factory quality interfaces, drive transition and sustaining of manufacturing processes, and uphold QMS compliance.

The position emphasizes Lean Six Sigma, design/document control, PFMEA, Gage R&R and regulatory standards. The role requires 3–7 years in medical device quality engineering, a engineering degree, and strong communication with customers and suppliers.

Qualifications

• 3–7 years of experience in Quality Engineering or adjacent role in medical device/manufacturing.
• Bachelor’s degree in engineering or related discipline.
• Experience interacting with customers and suppliers in a professional manner.
• Experience with databases and BI tools; working knowledge of statistical software.
• Experience managing multiple priorities among stakeholders.
• CQE and/or Six Sigma Green or Black Belt preferred.

Responsibilities

• Serve as a lead Quality Engineer on development projects; contribute to Design History File/Device Master Record and product builds.
• Monitor and disseminate customer quality alerts and process deviations.
• Lead troubleshooting during product launches and support Product Development Process.
• Lead development of metrology equipment.
• Develop and maintain quality/control plans and PFMEA.
• Ensure QMS procedures and regulations are used in development.
• Develop risk documentation per QMS and regulatory standards (e.g., PFMECA).
• Conduct Gage R&R studies and Design of Experiments.
• Develop Quality Procedures and train personnel.
• Approve nonconformance disposition.
• Analyze production and validation data with advanced statistics.
• Support continual improvement and process assessment projects.
• Author protocols or support qualification/validation in design control.

Skills

Lean Six Sigma

Quality Engineering

Gage R&R

Process Validation

Process Development

Statistical software

Customer interaction

ISO 13485

21 CFR 820

Education

Bachelor’s degree in engineering or related discipline

Tools

Power BI

Tableau

Statistical software

Job description

Agile Search is seeking a mid–senior Quality Engineer for an onsite role in San Diego (92121). You will support customer and factory quality interfaces, drive transition and sustaining of manufacturing processes, and uphold QMS compliance.

The position emphasizes Lean Six Sigma, design/document control, PFMEA, Gage R&R and regulatory standards. The role requires 3–7 years in medical device quality engineering, a engineering degree, and strong communication with customers and suppliers.