Plant manager

•	Responsible for determining if the Quality Management System is suitable and effective.
•	Ensure that quality documentation is current and is properly authorized and controlled.
•	Ensure the QC testing and release of manufactured product (AAMI tests)
•	Ensure internal, key vendor, and product quality audits are completed as prescribed 
•	Represent the plant for all audits conducted by the FDA, notified bodies, partner companies and corporate audits. 
•	Ensure Design Transfer is properly completed for product changes and new product implementation.
•	Manage personnel activities including hiring, training, development and performance management. 
•	Assure completion of process validation in Manufacturing (IQ/OQ/PQ).
•	Analyze defects and process problems to determine trends and recommend corrective action and/or changes in inspection criteria.
•	Ensure processes and procedures meet requirement of, (ISO-13485, FDA/GMP), CFR and other regulatory requirements as well as the Corporate Quality Management System Requirements. 
Medical Devices: Protective apparel, Isolation gowns, chemotherapy gown, surgical gowns, drapes, reusable wrap, drapes, polypropylene products.

•	In charge of the 1000 employees producing 190,000 garments per week for the follow customers: Nike, Patagonia, Converse, Reebok, Fanatic, Air Jordan
•	 In charge for Lean implementation, improve the quality, efficiency, delivery, turnover and absenteeism indicators
•	 On time performance and reduce the lead time.
•	 In charge of all operative area in the plant: Production, Quality, Engineering, HR, Mechanics, training, planning.
•	 Plan, control and supervise the execution of the production plan, set in goals and objectives.
•	 Verified the balancing of production areas according to shifts and provide necessary resources.
•	 Established strategies and improvement projects for the daily compliance of the cutting and sewing plan, together with the managers under his charge
•	 Participated in the development of short and long range plans and budgets based on established objectives and goals.
•	 Lead the development and implementation of procedures and controls for continuous improvement.
•	 Established and monitor the KPIS with the managers in charge evaluating compliance
•	 Participate and follow up on internal and external audits when appropriate.
•	 Perform sewing and cutting spread aligned to forecast according to demand.

•	In charge of all operative areas in the plant, this include Sewing Production, Cutting Room, Engineering, Quality, Maintenance, Human Resource, Fabric Warehouse, Purchasing, Laundry, Safety & Hygiene
•	In charge of the production and shipping of 4,000,000 uniforms per year, this include products like Flame resistant work shirt, hi-visibility work shirt, Jeans regulars and flame resistant, jackets, coveralls.
•	Balance the sewing lines, monitoring the production every hour, work with the bottle necks to get the daily goal
•	In charge to cut 200,000 pieces per week to 3 factories of the company, this include, pants, cargo pant, short, coats, coverall, work shirt, jackets
•	In charge of 700 employees, 620 directs and 80 indirect, giving to the employees the best conditions of security and Hygiene
•	Determine and maintain the budgeted DL cost
•	Determine and maintain the budgeted OH cost
•	Ensuring the appropriate development of the personnel assigned to the plant and maintaining the labor to fulfill established production goals
•	Develop systems and processes that track and optimize productivity and standards, metrics and performance targets to ensure effective return on assets.
•	Responsible to maintain the ISO9001-2015 certification

•	In charge of the application of the system of quality management through the creation, application, verification and maintenance procedures to ensure product quality and processes applying: FDA-21 CFR part 820, ISO9001: 2008.ISO13485 medical devices.
•	 Analysis and improvement of quality indicators in the three factories in Grupo Karims in Mexico, (2,000 employees), plans corrective and preventive.
•	 Provide accurate data to corporate offices in all areas affecting the quality of garments and to provide statistical measurements of the facilities.
•	 Work with Plant Managers on the in line auditors in measuring, controlling or improving the process steps in assuring that Quality Standards are followed. 

Brands: Medline, Kimberly Clark, A4, Next Level, Fruit of the Loom,
Products: Scrub Pants, Scrub Tops, Disposable Gowns, Pediatrics, Patient Gown, Surgical Gown, Isolation Gown, T-shirt, Short, Tank Tops, Underwear.

Ingeniero Industrial