Medical Device Quality Engineer — Process & Compliance

Vantedge Medical Company; Rancho Cordova (CA); On-site; USD 90,000 - 115,000; Full time

Job summary

Vantedge Medical Company is seeking a Quality Engineer for a full-time, onsite role in the United States. The candidate will support product and process quality activities, drive improvements, and ensure ISO 13485 compliance within a medical device manufacturing environment.

Responsibilities include CAPA analyses, supplier quality collaboration, and development of validation protocols while maintaining quality metrics across production.

Qualifications

• 4-year degree in Quality/Mechanical/Industrial engineering or related
• Experience in medical device/manufacturing quality environments preferred
• Strong knowledge of quality tools and problem solving methods

Responsibilities

• Generate internal quality reports based on CAPA, complaints and yield.
• Propose and drive product/process improvement initiatives.
• Work with suppliers and Supply Chain to improve performance.
• Maintain metrics to evaluate process performance with manufacturing.
• Coordinate PPQP activities (pFMEA, CP, Capability reports, GR&R).
• Assist the Director of Quality in maintaining ISO 13485 QMS.
• Create/Update work instructions and procedures as needed.
• Lead and/or create equipment validation protocols and reports.

Skills

Quality problem solving

CAPA management

Statistical analysis

Education

4-year degree in Quality/Mechanical/Industrial engineering

Tools

Minitab

JMP

Job description

Vantedge Medical Company is seeking a Quality Engineer for a full-time, onsite role in the United States. The candidate will support product and process quality activities, drive improvements, and ensure ISO 13485 compliance within a medical device manufacturing environment.

Responsibilities include CAPA analyses, supplier quality collaboration, and development of validation protocols while maintaining quality metrics across production.