Ernesto Chacon Email & Phone Number

Mexico

Digital manufacturing.

Reynosa, Tamaulipas, Mexico

Responsible for 1,200 employee base. Plastic Injection Medical Device FDA registered operations. In depth practice of FDA 21CFR.820 (QSR), Part 11 and ISO 13485 certified Facility. Particle controlled room more than 100+ injection molding machine and high-speed automation.

Guadalajara, Mexico Metropolitan Area

Responsible for Medical Devices Plant Electronics. (SMT and Assembly), and Sheet Metal Fabrication Operations. | GMP fundamentals deployed.

• 3 building Operations, More than 2,500 employees. Electronic Assembly, consumer, medical and industrial. Assured consistent quality of production by implementing and enforcing automated practice systems.
• Managed quality assurance team and act as operations director for medical business.
• Responsible for plant certifications for: ISO9001, AS9100, ISO/TS16949 and ISO13485 and operate as per FDA Registrar on QSR.820 Class II products.
• Monitor vendor performance and establish criteria and rating system for critical vendors. Oversee calibration and testing protocols.Achievements:
• Zero major non-conformities for all standards. No 483's.
• Reach quality targets DPPM < 1000 DPPM for Industrial. Two-digit for automotive and medical devices customers.

• Plastic Injection molding Facility. more than 80 machines for consumer products, toys industry and sharp collectors for medical devices. 2,000 employee base.
• Standardize processes and streamline workflow.
• Implement QSR 21 CFR.820 rules QM Role, and EHS Manager (acting 2007-2010).
• Establish a QMS based on corporate rules and regulations for a new the site in Cd. Juarez (2007-2010). Guarantee a safe launch plan for Medical Devices in Plastic Injection for class II devices, sharp collectors for.
• Drive Kaizen Shingijutsu events every quarter, part of the Plant Coach leadership to identify improvement projects on TML, Labor Optimization, etc. Through waste elimination.
• Received the Safety State Award for Flex GDL while leading EHS. Graduated from Emerging Leaders Program & Employee of the month several times

• Drive corrective and preventive actions at leadership level to accomplish project closure and recurrence control, providing necessary resources and clearing roadblocks. Implement process controls in assembly lines for.
• Product Safety Engineer in charge of performing electrical and mechanical under IEC60950. Lead internal ISO9001 audits, and deploy QMS Global practices. Achievements:
• Employee developing program, assigned to R&D Facility in Arizona to learn Lab test for IEC. Implement QMX, set all support databases for ISO. * SPC module implemented.