Chihuahua, Mexico
Engineering professional focused on the quality & process validation field for medical device manufacturing. Deliver products with high quality, contribute for the best customer service possible and innovate quality engineering controls are my goals.
Communication across company sites for resolution of complex issues impacting the quality and delivery of products manufactured in the Juarez facility. Implementation of pilot line of electronic eDHR solutions, serving as leader of development team and part of the steering committee for digital transformation. Actively participating on Kaizen-Shingijutsu continuous improvement initiatives, leading projects related to LPA, Waste reduction, Efficiency & Quality Day to day sustaining quality operations on manufacturing and packaging areas. Working with OEMs representatives to sustain the quality metrics and deploy continuous improvement initiatives on the manufacturing & inspection processes. Leading non design changes on the manufacturing & inspection processes to strengthen the operation and quality controls thought implementation of automatic & semiautomatic equipment/MSA systems. Actively collaborating & participating with internal & external audit to the site QMS, audit based on FDA CFR 820, CFR 11 & ISO 13485:2016. Certified internal auditor on ISO 13485:2016 by BSI. Managing capital & spend resources for the quality department. Mentoring quality, process & project engineers for process, software & test method validation site/industry guidelines, as well during process development of a NPI/transfer product.
Leading resources, strategy and execution for a FDA Import Alert removal project, successfully accomplish removal from the red list. Leading resources & validation strategy for cost saving & synergy projects. Validation Lead for the BD Homecare Juarez site by providing guidance, feedback and approval to validation strategy, protocols & reports for NPI, product transfers and control changes on current processes. Working with cross-functional teams to develop all stages applicable for NPI, product transfers & process improvements SAT, FAT, EOF, DOE, IQ, OQ, PQ, SV, TMV
Responsible for create, implement & maintain quality controls in manufacturing areas Conducting validation testing for catheters manufacture lines (IQ, OQ, PQ) Managing internal & external (division facilities) non conformances Conducting during 1 year validation testing (IQ, OQ, PQ) & QA assesment for packaging process transfer from Rochester Medical to BARD Creation of quality inspection procedures and test methods for packing areas Lot releasing process to sterilization and distribution. Problem solving for CAPA, NCR applying quality core tools (8D, 5w etc.) statistical techniques (regression, hypothesis, R&R, capability Index etc) Site validation lead, deployment of the BD validation tool kit in multiple training sessions locally and other BD facilities, responsible for tracking the site master validation plan.
Managing finish good product inventory, Ensure delivery of work orders to sterilization and distribution along three facilities in El Paso TX, logistics, supply chain through Milestone schematic and customer service.
In charge of the supplier quality role for the plant, IQC, MRB control, RMA's, product tractability investigations, coordinating QA warehouse product & process audits, costumer and internals complaints about raw materials and regulatory affairs.
Development Kaizen projects for energy savings, maintenance management (training, procedures etc.), coordinating and assisting with corrective and preventive maintenance to equipment, work orders control and using lean manufacturing tools for improvements.