Senior Quality Engineering Specialist (Waterloo)

Position Overview

Senior Quality Engineering Specialist (Medical Device)

Location: Waterloo, Ontario

Compensation Range: $95,000.00 - $120,000.00 per year

AT NDI, a global leader in optical and electromagnetic tracking technology, partners with top medical device OEMs to develop navigation platforms from concept through commercialization.

Key Responsibilities

Reporting to the Senior Manager, Quality Assurance & Regulatory Affairs, the Senior Quality Engineering Specialist supports NDI products throughout the full product lifecycle—development, commercialization, and post‑market performance—to ensure compliance with safety, performance, and regulatory requirements.

• Lead quality engineering activities across the product lifecycle, including design, transfer, and post‑market support.
• Own and ensure compliance with ISO 13485, FDA 21CFRPart820, and other global regulations.
• Provide expert leadership in design ...