A plastics and medical device company in Buffalo Grove, IL is looking for a Quality Engineer.

RESPONSIBILITIES:

• Validation of quality processes by establishing product specifications and quality attributes
• Support pharmaceutical and biotechnology clients with projects in varying developmental and FDA approval stages
• Assisting with documentation and project work from clients
• Coordination and participation in the IQ/OQ/PQ validation process
• Coordination and leading the full life cycle of investigations regarding customer complaints including creating process control plans, pFMEAs, risk analysis, etc

REQUIREMENTS:

• High School Diploma or GED equivalent required (Bachelor’s degree in Engineering, Science or related field strongly desired)
• 3+ years of experience in a Quality related position, either in medical device or aerospace manufacturing. Injection molding experience preferred. 
• 3+ years of medical device and/or aerospace manufacturing validation experience (IQ/OQ/PQ or PPAP) and/or customer complaint investigation/management
• Excellent customer-facing experience and communication skills
• Advanced knowledge and ability to apply mathematical concepts and intermediate statistical (SPC) knowledge.
• Six-sigma experience (training or certification) preferred
• Experience with computer skills, preferably Microsoft Office, SAP, and Minitab

SALARY INFO:

$35 - $43 / HR