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Quality Engineer

Geopaq Logic
Walton, KY Full Time
POSTED ON 2/25/2025
AVAILABLE BEFORE 5/5/2025

Position : Quality Engineer

Location : Walton, KY

Job Summary :

Seeking an experienced Quality Engineer with at least 3 years of experience in food or medical device industries . Preferred candidates hold an ASQ CQE certification and have knowledge of FDA 21 CFR Part 820 / 821 and ISO 13485 : 2016 standards.

Responsibilities :

  • Ensure product quality and compliance with ISO 13485 & FDA regulations .
  • Develop procedures, specifications, and inspection methods .
  • Support manufacturing & supplier validation .
  • Manage nonconformance issues & corrective actions .
  • Create audit plans, production reports, and supplier assessments .
  • Work with cross-functional teams to maintain quality standards.

Requirements :

  • 5 years of medical device experience (Required).
  • 1 year of FDA regulations & CGMP experience (Required).
  • Bachelor's Degree (Preferred).
  • Forklift & hazmat experience (Preferred).
  • Strong problem-solving & documentation skills .
  • Benefits :

  • 401(k), Health, Dental, Vision, Life Insurance
  • Paid time off & Referral program
  • 8-hour day shifts, in-person work
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