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