Quality Engineer

BASIC FUNCTION

This position resides in the Quality Department with responsibility for assisting in the planning, development, implementation, communication and maintenance of the quality management system.

MAJOR RESPONSIBILITIES

1. Assist the Quality Manager in implementing, establishing, and maintaining the company quality system in accordance with ISO 13485:2016 and FDA 21 CFR Part 820.
2. Provide support with various Quality Processes such as: Corrective and Preventative Action System, Non-conforming Material, Customer Complaints, Validation, Supplier Evaluation, and Employee Training. 
3. Improve and Maintain calibration and preventative maintenance systems.
4. Improve existing and develop new quality and inspection processes, writing and implementing associated procedures and other documentation.
5. Generate and maintain Key Performance Indicators.
6. Perform Root Cause analysis and Risk Assessment to resolve Quality Issues.
7. Perform product testing on finished product as well as component product, including physical testing, tensile strength testing, destructive testing, and simulated use testing.
8. Perform accurate mechanical, physical, and visual inspection when required as per specifications utilizing various measuring equipment (i.e., calipers, micrometers, tensile tester, etc.).
9. Ensure products adhere to company and industry quality standards.
10. Comply with all quality, safety, and work rules and regulations.
11. Perform other duties as assigned.