The Quality Engineer will provide support to Projects. Must be able to perform Test Methods for Incoming Inspection, Final Release Test Method Validation/Qualification such as but not limited to all Components and End Items. In addition knowledge in Statistical Process Control and be able to review/perform validations (IQ, OQ, PQ).
Bachelor Degree in Science or Engineering and minimum of 5 years of experience in the pharmaceutical, Medical Device or other FDA regulated industry.
Ultimate Solutions Corp is an Equal Opportunity Employer
- Experience working with Test Methods for Incoming Inspection
- Test Method Validation/Qualification
- Risk Assessment
- Support and approve all documentation required for project deliverable
- Plan, write, coordinate, execute, summarize, review validation protocols, transfer plan validation
- FAT, SAT, Commissioning, CSV, IQ, OQ, PQ, Deviations, results and approvals for Equipment and Tooling.
- Set-up of Incoming Inspection equipment, ensure satisfactory operation and train on inspections
- Generate new MP’S, IP’s, TM’s and obtain approvals