Work Flexibility: Onsite

What you will do​ 

​Ensure quality of process and product as defined in the appropriate operation and material specifications. ​Will assist in the selection of components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols. ​Support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation. ​Will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings. ​Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches. ​Complete capability studies for in process inspection and generate subsequent Inspection documentation.     ​Conduct MSA studies for new products and new processes. ​Ensure adherence to GMP and safety procedures. ​Review and approval of validation documentation.

What you need

Required:

B.S in Industrial Engineering or related engineering discipline;Minimum 6 months of similar experience in a Regulated Industry;Bilingual in English and Spanish;Knowledge of manufacturing processes, materials, product and process design;Experience with ERP, preferably SAP.

Preferred:

Understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques;

Travel Percentage: 10%