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QA MANAGER
Customer and quality focused business professional who provides the strategic vision and leadership that drive Quality, operational process, productivity, efficiency and bottom-line improvements. Bilingual Operations manager with 7 + years of management experience demonstrating year-over-year a consistent success in achieving Quality improvements, revenue, cost, productivity and delivery goals with a strong qualification in day-to-day manufacturing operations including field experience in planning and executing strategies to transfer technology. Have deployed LEAN by developing the strategy and personnel. Background includes more than 20 years experience in the Engineering and Quality functions, ISO 13485 Lead auditor, change management and recognized for high-profile turnaround achievements affecting revenue, stability, and profitability. Solid knowledge and experienced implementation of ISO 9000, ISO 13485, Lean Six Sigma and other formal Quality/productivity/performance improvement initiatives Lean Manufacturing, QFD, and Kaizen Blitz.
CORE COMPETENCIES
Regulatory Compliance Management, LEAN tools and strategies implementation, Quality Management System, Cost Control Strategy, GMP guidelines and procedures, KPI definition and improvement, budget planning and Quality Supply Chain Management, Certified CQE by ASQ and ISO 13485 lead auditor by BSI.

PROFESSIONAL EXPERIENCE
TE Connectivity Energy 03/14 to 06/16
Quality Manager for the injection molding, rubber molding, machining and assembly plant of multiple products used in connections for the electricity distribution industry. ISO 9001 re-certification.

IDEX Knight LLC. 04/13 to 03/14
Liquid dispensing and mixing manufacturer that assembles and tests sanitary equipment used in farms, restaurants and hospitals. I was hired to implement and certify an ISO 13485 compliant Quality System. System was implemented and certified by BSI.
My position was Quality Leader for the entire corporation. Reported directly to the President of the company.

REXAM Healthcare Juarez SA de CV. 03/09 to 04/13
Medical contract manufacturer that assembles and tests to customer specifications mostly packaging and delivery systems.
My position was QA/Engineering/Regulatory Affairs Manager and Quality site coordinator for the Juarez and Mexico City plants. The Mexico City plant is a molding facility (blow, injection and extrusion)
Current responsibilities include managing the mentioned departments with a 150 non union employees. Act as a Quality site coordinator for the Mexico city molding plant. Juarez plant ISO 13485 Re-certification in 2010, Mexico city ISO 13485 and ISO 9001 certification in 2012. Comply with internal audit schedules, LEAN implementation coordinator in the Juarez plant which includes the implementation of the LEAN tools such as Six Sigma, VSM, TPM, SMED and 5S. Six Sigma coordinator. Customer complaint reduction of 25% in the first year. Updated GMP procedures for the plant, Implemented a more effective corrective action response procedure using the 8Ds methodology. Implemented one piece flow and operation re-balancing in assembly lines with an efficiency improvement of 14%. Designed and built new clean room. Lead the business excellence deployment at the site including integration into both daily operations and long term strategy optimizing operational and financial goals identified by the corporation’s business model. Change Agent: Over the last 15 months contributed in the transformation of struggling business unit by using Kaizen principles that improved Quality, line efficiency, reduced scrap in 2% and increased line capacity.

Plasticos Promex Cd. Juarez, Chih. 12/06 to 03/09
Molding Contract Manufacturer with 280 non union employees that molds and assembles components for customers like ELECTROLUX, Philips, Honeywell Security and Hoover.
QA Manager
Manage the QA department and achieved ISO 9001 certification in the first year. Implemented the AIAG APQP and PPAP processes. Improved lot acceptance percentage at customer from 94% to 98.5%. Reduced customer complaints 20% in two years. Introduce SPC for critical dimensions. Established KPIs for the plant. Direct all plant activities to ensure timely execution of scheduled internal audit, regulatory agency inspections and customer audits. Optimize Quality inspections operations intra-processes to reduce the number of inspectors. Meet financial and delivery goals identifying, prioritizing and complete top projects that could impact company business budget and objectives in a timely manner with full P&L responsibility for in-house customers. Change Agent: Implemented and achieved ISO 9000 certification in six months. Established a quality and customer focus oriented culture.

CORDIS de México SA de CV Cd. Juárez, Chih. 3/03 to 12/06
Medical device manufacturer with 1500 union and non union employees that assembles stent delivery devices, catheters, guide wires and coated and non coated stents for house brand.

SR. Quality Engineer
Initially hired as a Sr. Quality Engineer for the introduction of new products. In this position was in charge of the QA activities for the design, validation and transfer of new products. Wrote and reviewed validation protocols, participated in product design review sessions. Later was moved to manage the QA activities for 4 stent delivery system assembly lines. Coordinated the inspection activities of 8 QA inspectors, Wrote and review validation protocols, assembly instructions and inspection procedures. KAIZEN team leader for two projects (one Kaizen blitz and the other continuous improvement project for scrap reduction). Customer complaint response reviews and follow up.

EDUCATION & TECHNICAL CERTIFICATIONS
University of New Mexico Las Cruces / Master of Science courses in Advanced Manufacturing Engineering. Incomplete
Universidad Autonoma de Cd. Juarez / Finished studies en Electrical Engineering.
REXAM / Six-Sigma Black Belt without certification.
ASQ/ Certified Quality Engineer in 2005
BSI/ Certified Lead Auditor in 2013

ADDITIONAL COURSES
Medical devices: Class III – MDD, Class II – FDA, for different human applications and for stent delivery applications. ISO 13485, ISO 9001, FDA GMP requirements, Value Stream Mapping Strategies and Cycle time reduction, 5S, SMED, One piece flow, Time Management, Developing Management skills, DFMEA, PFMEA, APQP, PPAP.","rawText":"Lorenzo Manuel Ibarra Mejia QA MANAGER Customer and quality focused business professional who provides the strategic vision and leadership that drive Quality, operational process, productivity, efficiency and bottom-line improvements. Bilingual Operations manager with 7 + years of management experience demonstrating year-over-year a consistent success in achieving Quality improvements, revenue, cost, productivity and delivery goals with a strong qualification in day-to-day manufacturing operations including field experience in planning and executing strategies to transfer technology. Have deployed LEAN by developing the strategy and personnel. Background includes more than 20 years experience in the Engineering and Quality functions, ISO 13485 Lead auditor, change management and recognized for high-profile turnaround achievements affecting revenue, stability, and profitability. Solid knowledge and experienced implementation of ISO 9000, ISO 13485, Lean Six Sigma and other formal Quality/productivity/performance improvement initiatives Lean Manufacturing, QFD, and Kaizen Blitz. CORE COMPETENCIES Regulatory Compliance Management, LEAN tools and strategies implementation, Quality Management System, Cost Control Strategy, GMP guidelines and procedures, KPI definition and improvement, budget planning and Quality Supply Chain Management, Certified CQE by ASQ and ISO 13485 lead auditor by BSI. PROFESSIONAL EXPERIENCE TE Connectivity Energy 03/14 to 06/16 Quality Manager for the injection molding, rubber molding, machining and assembly plant of multiple products used in connections for the electricity distribution industry. ISO 9001 re-certification. IDEX Knight LLC. 04/13 to 03/14 Liquid dispensing and mixing manufacturer that assembles and tests sanitary equipment used in farms, restaurants and hospitals. I was hired to implement and certify an ISO 13485 compliant Quality System. System was implemented and certified by BSI. My position was Quality Leader for the entire corporation. Reported directly to the President of the company. REXAM Healthcare Juarez SA de CV. 03/09 to 04/13 Medical contract manufacturer that assembles and tests to customer specifications mostly packaging and delivery systems. My position was QA/Engineering/Regulatory Affairs Manager and Quality site coordinator for the Juarez and Mexico City plants. The Mexico City plant is a molding facility (blow, injection and extrusion) Current responsibilities include managing the mentioned departments with a 150 non union employees. Act as a Quality site coordinator for the Mexico city molding plant. Juarez plant ISO 13485 Re-certification in 2010, Mexico city ISO 13485 and ISO 9001 certification in 2012. Comply with internal audit schedules, LEAN implementation coordinator in the Juarez plant which includes the implementation of the LEAN tools such as Six Sigma, VSM, TPM, SMED and 5S. Six Sigma coordinator. Customer complaint reduction of 25% in the first year. Updated GMP procedures for the plant, Implemented a more effective corrective action response procedure using the 8Ds methodology. Implemented one piece flow and operation re-balancing in assembly lines with an efficiency improvement of 14%. Designed and built new clean room. Lead the business excellence deployment at the site including integration into both daily operations and long term strategy optimizing operational and financial goals identified by the corporation’s business model. Change Agent: Over the last 15 months contributed in the transformation of struggling business unit by using Kaizen principles that improved Quality, line efficiency, reduced scrap in 2% and increased line capacity. Plasticos Promex Cd. Juarez, Chih. 12/06 to 03/09 Molding Contract Manufacturer with 280 non union employees that molds and assembles components for customers like ELECTROLUX, Philips, Honeywell Security and Hoover. QA Manager Manage the QA department and achieved ISO 9001 certification in the first year. Implemented the AIAG APQP and PPAP processes. Improved lot acceptance percentage at customer from 94% to 98.5%. Reduced customer complaints 20% in two years. Introduce SPC for critical dimensions. Established KPIs for the plant. Direct all plant activities to ensure timely execution of scheduled internal audit, regulatory agency inspections and customer audits. Optimize Quality inspections operations intra-processes to reduce the number of inspectors. Meet financial and delivery goals identifying, prioritizing and complete top projects that could impact company business budget and objectives in a timely manner with full P&L responsibility for in-house customers. Change Agent: Implemented and achieved ISO 9000 certification in six months. Established a quality and customer focus oriented culture. CORDIS de México SA de CV Cd. Juárez, Chih. 3/03 to 12/06 Medical device manufacturer with 1500 union and non union employees that assembles stent delivery devices, catheters, guide wires and coated and non coated stents for house brand. SR. Quality Engineer Initially hired as a Sr. Quality Engineer for the introduction of new products. In this position was in charge of the QA activities for the design, validation and transfer of new products. Wrote and reviewed validation protocols, participated in product design review sessions. Later was moved to manage the QA activities for 4 stent delivery system assembly lines. Coordinated the inspection activities of 8 QA inspectors, Wrote and review validation protocols, assembly instructions and inspection procedures. KAIZEN team leader for two projects (one Kaizen blitz and the other continuous improvement project for scrap reduction). Customer complaint response reviews and follow up. EDUCATION & TECHNICAL CERTIFICATIONS University of New Mexico Las Cruces / Master of Science courses in Advanced Manufacturing Engineering. Incomplete Universidad Autonoma de Cd. Juarez / Finished studies en Electrical Engineering. REXAM / Six-Sigma Black Belt without certification. ASQ/ Certified Quality Engineer in 2005 BSI/ Certified Lead Auditor in 2013 ADDITIONAL COURSES Medical devices: Class III – MDD, Class II – FDA, for different human applications and for stent delivery applications. 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