Resourceful professional skilled in promoting enhancements to team and company success while maintaining conformance to established and emerging regulations. Certified in Lean Six Sigma Green Belt.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs Coordinator
Genomi-k
Monterrey
03.2023 - Current
Collaborated across internal departments to achieve regulatory objectives and maintain compliance of products.
Evaluated changes to documents submitted to determine need for amendments.
Collaborated with cross-functional teams to interpret and communicate new and revised ISO 9001: 2018 requirements.
Researched new regulatory requirements for the products & services to gather information and launch resulting organizational changes.
Jr. Production Engineer
Mando Halla Co.
Saltillo
09.2020 - 12.2021
Wrote engineering documentation, developed manufacturing processes, equipment specifications and change notices and implemented modifications.
In charge of updating, creating, and correcting work standards, cycle times, production plans, FMEAs for the Break business unit.
Launch of new products, and models with core tools (PPAP, MSA, SPC, CP, FMEA, APQP).
Continuous Improvement Intern
Ragasa
Monterrey
11.2018 - 12.2019
Project administration and Continuous Improvement initiatives of Ragasa where 100% of the personnel interacts, for support and internal movements, registrations, and cancellations, permits authorizations, and personnel’s Kardex updates.
Organized and helped design training qualifications for the usage of OPTIM System (Internal system for Continuous Improvement Optimization).
Key Process Indicators design for follow-up modulus of internal benefits & rewards system.
Helped in follow-ups of Continuous Improvement projects and plant events Six Sigma Related (Kaizen, DMAIC, Just Do-IT, SMED, etc.).
Leader in internal supply project with identification of failures, and reduction of waste and time.
Clinical Research & Regulatory Affairs Coordinator at Center for Podiatry CareClinical Research & Regulatory Affairs Coordinator at Center for Podiatry Care