Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
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 crossfunctional teams to maintain quality standards.
Requirements:
- 5 years of medical device experience (Required).
- 1 year of FDA regulations & CGMP experience (Required).
- Bachelors Degree (Preferred).
- Forklift & hazmat experience (Preferred).
- Strong problemsolving & documentation skills.
Benefits:
- 401(k) Health Dental Vision Life Insurance
- Paid time off & Referral program
- 8hour day shifts inperson work
CGMP
Employment Type
Full Time
