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;