Senior Quality Engineer, Medical Devices & IVD; FDA​/IVDR

Tempus AI
Boston, US
On-site

Job Description

Position: Senior Quality Engineer, Medical Devices & IVD (FDA/IVDR)

A healthcare technology company seeks a Lead Quality Engineer in Boston to oversee quality assurance for medical devices. The role requires 5+ years of experience in the regulated industry, a BS in Engineering, and proficiency in regulatory requirements. The Lead Quality Engineer will be responsible for compliance with FDA and EU standards, implementing quality assurance practices, and coordinating technical documentation.

This onsite position offers a competitive salary range of $110,000–$155,000, with a full benefits package.

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Skills & Requirements

Technical Skills

Healthcare

Salary

$110,000 - $155,000

year

Employment Type

FULL TIME

Level

lead

Posted

4/16/2026

Apply Now

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