- Follow up on supplier audits to demonstrate controls required by FDA CFR 820, ISO 13485, and ISO 9000
- Collaborate with suppliers to identify and address issues
- Prepare detailed reports and effectively communicate results to stakeholders
- Ensure timely implementation of supplier corrective actions
- Provide engineering support for material and authorization issues
- Support supplier file remediation and business development activities
- Verify and maintain supplier files as needed
- Provide supplier metrics for management review
- Lead supplier approval process and develop improvement plans
- Manage personnel to enhance inspection cycle efficiency
- Establish problem-solving strategies to reduce inventory
- Analyze component characteristics to optimize inspection processes
- Requirements:
- Familiarity with FDA CFR 820, ISO 13485, and ISO 9000
- B.S Degree in Engineering
- Minimum 5 years of quality auditing experience
- Excellent communication and problem-solving skills
- Proficiency in English
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Supplier Quality Engineer - Cleveland, United States - Stefanini, Inc
Description
Supplier Quality Engineer Opportunity at Stefanini Group
Stefanini Group is currently seeking a Supplier Quality Engineer in Cleveland, MS for a challenging yet rewarding role.
Work Hours: Monday to Friday (40 hours weekly)
Work Location: Cleveland, MS
Shift: 1st Shift
Note: Salary ranges are competitive and dependent on experience and qualifications, with possible additional benefits. Stefanini is dedicated to recruiting top talent and fostering relationships with our employees. We ensure transparent communication throughout the hiring process.
About Stefanini Group: Stefanini Group offers a wide range of outsourcing, IT consulting, and staffing solutions to global enterprises. With a strong presence across multiple continents and industries, we are committed to delivering exceptional services to our diverse client base.