Position: Quality Engineer

Location: Walton, KY
Full Time

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