Houston Metro Area, TX
Serving as Supplier Quality Engineer (SQE) representative to work with supplier on multi-department projects.
-Reviewing supplier QMS documentation and ensure the document complies with regulatory, industry internal requirements (including SOP, work instruction and validation documents).
-Serving as SQE liaison and working with supplier on validation projects, process mapping projects and nonconformance resolutions and CAPAs.
-Travel to supplier site and represent Alcon to interact with supplier.
- Working knowledge of FDA QSR and ISO 13485
- Experience with process validation including IQ, OQ and PQ.
- Experience with technical writing, including procedures, validation protocols and reports.
- Fluent with MS Office Suite.
- Able to travel to Mexico on monthly basis.
- Bilingual (English and Spanish) is a plus (not required).