Quality Engineer 1

Duration: 12 months

Position Overview 
This position is for a Quality Coordinator for the Nonconformance process. This person will work with Quality Engineering and Product Engineering to prioritize and complete nonconforming material reports. 
The person in this role will: 
• Investigate material nonconformances 
• Document nonconformances in SAP 
• Document trend analysis 
• Coordinate Material Review Board meetings 
Responsibilities: 
This position will be responsible for prioritizing the investigation and disposition of nonconforming materials to ensure reports are completed in a timely manner. 
• Drive completion of nonconformance records in a timely manner 
• Attend daily production meetings to represent nonconformance group 
• Work cross functionally to properly document nonconforming materials 
• Create reports using Microsoft Excel for nonconforming materials for analysis 
• Maintain control of nonconforming materials 
• Perform investigations 
• Initiating Product Holds, when necessary 

Required Knowledge/Skills, Education, and Experience 
• Experience working in manufacturing for medical device, pharmaceutical or other regulated industry 
• Strong organizational skills and ability to prioritize and attention to detail 
• Understanding of nonconformance and CAPA processes required 
• Working knowledge of Microsoft Excel, including basic formulas and pivot tables 
• Ability to communicate effectively within a technical environment 
• Ability to physically pick up and move materials 

Preferred Knowledge/Skills, Education, and Experience 
• Associates or technical degree with coursework in engineering preferred, but not required 
• Experience working with SAP Quality Notification, or other nonconformance tool preferred

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