What are the responsibilities and job description for the Quality Engineer position at Extension, Inc?
Extension is seeking a Quality Engineer for a direct-hire opportunity with one of our clients located in Butler, WI !
Key Responsibilities
- Lead validation activities (IQ/OQ/PQ) and author FDA-compliant protocols/reports
- Maintain and improve the QMS (ISO 9001, ISO 13485, FDA QSR)
- Support internal/external audits
- Investigate quality issues and drive CAPA/root cause analysis
- Support new and existing program quality planning
- Operate inspection equipment (OGP SmartScope preferred)
- Manage calibration system and documentation control
Qualifications
- Bachelor’s degree in Engineering
- 3 years in Quality Engineering in regulated manufacturing
- Experience in plastics/injection molding preferred
- Knowledge of ISO 9001, ISO 13485, FDA QSR
- Experience with validation, audits, and CAPA
Salary & Schedule
- Onsite in Butler, WI
- Monday-Friday, 7am-3pm
- $85,000 - $95,000 annually plus bonus
Salary : $85,000 - $95,000