Lead medical device quality engineering with FDA compliance, electromechanical expertise, and design verification experience at ECI. Contract or full time employment is available.

This senior engineering role supports life sciences consulting projects from concept through commercialization. You will guide quality decisions, documentation, design reviews, testing, validation, and regulatory compliance. The work emphasizes medical devices, quality systems, and systematic problem solving.

Key Responsibilities:

- Provide quality input for design decisions and project deliverables
- Develop quality plans, procedures, and regulatory documentation
- Lead acceptance activities, inspections, testing, and criteria
- Perform quarterly gap analyses and review verification documentation




- Support CAPA, NCRs, complaints, and special projects

Requirements:

- Four year degree and five to six years direct R&D; experience
- Medical device experience with electromechanical devices
- Cardiac pacemaker, monitoring system, and battery experience
- Knowledge of FDA quality systems regulations and standards
- Experience with SPC, DOE, GR&R;, FMEA, CAPA, and validation

Apply engineering, quality systems, and FDA compliance expertise to challenging medical device programs supporting ECI’s consulting clients.

📌 Senior Medical Device Quality Engineer (Quebec City)
🏢 Enhanced Compliance
📍 Quebec City