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Must-Haves:

3+ years of Quality Engineering experience (Class 2-3 Medical Devices). Highly proficient with Design Controls, specifically with Design History File (DHF) Remediation (21 CFR 820.30). Background with Gap Assessments/Analysis. Bachelor's Degree in Engineering or related field.

Plusses:

EUDMR Class 2-3 Experience

Experience required: 3-4 Years