Javier Cedillo Email & Phone Number

Reynosa, Tamaulipas, México

Reynosa, Tamaulipas, México

* Experience leading transfers, validation, quotations and implementation of new products Medical Devices regulated by FDA in accordance with requirements of ISO-13485. (510K, Device List Number, GTIN, Exp. Date, IFU, Artwork, Packing, Sterilization). * Coordination of raw material and equipment’s movement, quoting and buying equipment and tooling required for the transfer. * Tube Validation coordination in Extruders Machines for extension sets, infusion sets and bloodlines for human use and veterinary. (Pin, Vernier, Vision System, Laser Mike).* Experience in Mold components Validations (Pinch Clamps, Slider Clamps, Male Luer, Female Luer, Chambers, Filters, Spike, Inj. Sites). *Coordination and creation of documents for Validations (MVP, IQ, OQ, PQ,).*DWG development support of new medical products with their packing configuration for sterilization, Change Control of ECT in Packing. *Creation of documents necessary for product transfer (DMR, PFMEA, WI, PCS, DWG) based in ANSI/ASQC Z1 .4 and Quadrants of PFMEA. *Experience in Assembly Validation I Establish the sequence of operation for Engineering Run according to customer requirement and Lean Manufacturing. *Participation in Line balancing, results savings more than 30,000 dollars annually*Experience in Test based on ISO 8536 and establish the tests for the Medical Device (Leak Test, Pull Test). Based on ASTM D1876 (Peel Test) for Pouches and Use simulate test for hemodialysis Sets based in ISO 8638T. *Experience in Installation of equipment Printers, Leak Tester, Dispenser, Peristaltic Pump, Heat Cabin, welder ultrasonic machines, sealing machines.

Reynosa, Tamaulipas, México

*Creation of documents for Validations (MVP, IQ, OQ, PQ,).*Creation of documents necessary for product transfer (DMR, PFMEA, WI, PCS, DWG) based in ANSI/ASQC Z1 .4 and Quadrants of PFMEA*Experience in Test based on ISO 8536 and establish the tests for the Medical Device (Leak Test, Pull Test). Based on ASTM D1876 (Peel Test) for Pouches and Use simulate test for hemodialysis Sets based in ISO 8638T. *Experience in Installation of equipment Printers, Leak Tester, Dispenser, Peristaltic Pump, Heat Cabin, welder ultrasonic machines, sealing machines.* Coordination of raw material and equipment’s movement, quoting and buying equipment and tooling required for the transfer.

Reynosa, Tamaulipas, México

* Quality Control of final process. (Failures Report, Validation of process). * Analysis root cause of customer feedbacks using methodologies (5 W 1 H, 8 D, 5 Whys, Ishikawa Diagram) and perform activities for problem solution.* Coordination of activities to quality auditor and inspectors.* Supplier Feedback Attention and Modification of PFMEA.

Reynosa, Tamaulipas, México

* Creation and Modification of Incoming Documentation Inspection AQL. * Communication with Customer Motorola to get them approved for new critical parts.Experience to perform the Rohs test, soldering test, Encapsulation, X-ray and cross section.

Reynosa, Tamaulipas, México

* Creation of Sanmina Method will follow to reach the LLS score (Zebra business unit).MTBF (Mean Time between Failures).* OMS (Operation Machine Separation), coordination of 40 different processes of equipment getting a baseline and improve the test equipment automation removing as most as possible the manual steps making parallel times, eliminating the manual cable connection, results obtained 90%. And reduction of 1 to 2 sec. in cycle time. * I Worked on SMED project to reduce oven cycle time. I synchronize the models to run considering the temperature and models. For Run of lower to upper temperature and return the temperature.