Quality Engineer - FDA Job Detail           

Job Description:

The role of Quality Engineer is to support the Director of Quality in the implementation of the Quality System and to support Engineering and Manufacturing to ensure Quality parts are made in a safe, productive, and efficient environment and method. To effectively ensure the production and shipment of Quality parts as documented in the Empire Precision Plastics Quality Systems.

Duties:

• Continuous evaluation and improvement of Manufacturing Quality and Manufacturing Systems
• PDP (Process Documentation Program) development, maintenance and review
• Maintaining Certificates of Conformance files
• Lead and/or be part of Troubleshooting and Problem Solving teams
• Oversee the Gage Calibration/System
• Statistical analysis, capability studies, and PPAP generation
• Manufacturing and Quality personnel training 
• Internal auditing to ISO9001 and ISO13485 standards
• Scrap reduction
• Internal NCM processing
• Other duties as directed by the Director of Quality

Required Skills:

*FDA Regulations Required*

• Knowledge of Injection Molding and Manufacturing
• Knowledge and ability to implement Lean Manufacturing tools
• Blueprint reading & GD&T (Geometric Dimensioning and Tolerance)
• Experienced in use of all measurement equipment
• SPC (Statistical Process Control)
• Understanding of PPAP requirements
• Computer literacy using Word, Excel, etc.
• Good communication skills

Reports to:

Director of Quality

Work Environment:

Quality Laboratory

Physical Requirements:

Minimal lifting, normally less than 25 lbs

Educational Requirement:

High school diploma and Quality Engineering certification