Alejandro R Ferreira
Quality Manager at Align Technology Inc.
- El Paso, Texas Area
- Medical Devices
Alejandro R Ferreira's Overview
- Sr. Quality Manager at Align Technology Inc.
- Instituto Politecnico Nacional
Alejandro R Ferreira's Summary
A highly proficient, people, execution and results oriented bilingual senior Quality Manager with over 30 years’ experience within Medical Devices, Automotive, Aerospace, Telecommunications, and Consumer Products industries at global corporate, manufacturing, contract manufacturing, and supplier facilities with a proven track record in development and implementing quality management systems, and Continuous Improvement (CI) cultures while ensuring sustainable goals and objectives to provide world-class products in compliance to ISO 13485, ISO/TS 16949, ISO 9001, AS 9100, TL 9000, as well as regulatory regulations such as FDA Quality System Regulations (QSR) 21 CFR part 820, European Community Medical Device Directive (MDD) 93/42/EEC, Korea MDFS (former KFDA), Canadian Medical Device Regulations (CMDR) SOR 98-282, Japanese Regulations for Medical Devices (MLHW ordinance 169). Possessing strong project management skills, cross functional skills and techniques honed across multiple industries, I bring a fresh approach that utilizes my broad background, experience, and leadership to develop and implement a culture of robust and sustainable quality systems and operational improvements, goals and objectives. Experience in all aspects of quality assurance, domestic and international government regulations inspections, and customer audits. Excellent written and verbal interpersonal skills with the ability to work and communicate effectively with people at all levels using combined languages English-Spanish. A “Hands on” type of person in leading quality improvement teams, providing training in manufacturing process audits, internal audits, problem solving techniques and preventing.
Alejandro R Ferreira's Experience
Sr. Quality Manager
Public Company; 1001-5000 employees; ALGN; Medical Devices industry
2010 – Present (4 years) El Paso, TX/ Juarez, MX
Public Company; 1,000 employees; $500 million in sales; manufacturer of class II medical devices for malocclusion (misalignment of teeth) and traditional orthodontic treatment, intra-oral scanners and computer-aided design and computer-aided manufacturing (CAD/CAM) digital services used in dentistry, orthodontics, and dental records storage
Responsible for ensuring the smooth functioning of the quality assurance department to meet or exceed customer expectations in quality, delivery, value, and profit objectives of the company, accountable for implementing, maintaining, evaluating quality concerns/complaints / vigilance system, as well as device and component performance cycle from the field to the production floor, support process validation (IQ/OQ/PQ), Process Characterization for process improvements. Direct a group of 28 people with 3 direct reports (1 manager, 1general supervisors, and 1 quality system coordinator). Manufacturing competencies include: 3D digital scanning system, stereo-lithography, thermoforming polymer sheets, Laser marking, automated five-axis trimming machines (CNC), tumbling/de-burring, automated sorting/sequencing and bagging/packaging.
•Implemented new metrics for product performance which incorporating service data and failure analysis data. These data were correlated to complaints and manufacturing process metrics and determined action levels for CAPA
•Developed and implemented Quality System internal audits to meet FDA, Canadian, Japanese, Brazilian, Mexican and European regulations
•Successfully managed Korea MFDS GMP's inspection with no observations noted
•Developed and maintained a quality audit program resulting in several organizational improvements and being cited during 3rd party quality system audits as an area of high achievement
Privately Held; 1001-5000 employees; Medical Devices industry
2008 – 2010 (2 years) |El Paso, TX/ Juarez, MX
Privately Held; 900 employees; $60 million in sales; Contract manufacturer of Class I, II, and III medical devices used for cardiac rhythm management, interventional cardiology, neurology, and orthopedics, as well as urology and minimally invasive procedures (especially in the field of endoscopy)
Managed all QA functions across two manufacturing sites and a distribution center, coaching and mentoring 4 direct reports within QA compliance, training, QA laboratory, assuring all aspects of the site quality system and personnel are in compliance with applicable regulatory requirements. Represent site operations for FDA Inspections & Regulatory Submissions. Manufacturing competencies include: injection molding, pad printing
•Developed and implemented Quality System to meet FDA, Canadian, Japanese, Brazilian, Mexican and European regulations
•Played lead role in getting, ISO 13485:2003, ISO 13485:2003 CMDCAS TUV certifications
•Successfully managed FDA inspections to the manufacturing facilities and distribution center with no 483 citations
•Developed and implemented Quality Systems to meet FDA and European regulations
•50% reduction in supply chain defects and complaints in 2009
•30% reduction in cost of poor quality via six sigma
•Reduction of parts per million external defects at the customer by 35% in one year.
•20% reduction of internal parts per million defects ($0.9M)
•Set up and trained task forces to deal with chronic quality problems
•Established a process based supplier and internal audit program
Processes include plastic injection molding, laser welding, resistance welding, soldering, UV bonding, adhesive bonding, and crimping, swaging, assembly
Site Quality Manager
Public Company; 5001-10,000 employees; PLXS; Electrical/Electronic Manufacturing industry
2006 – 2008 (2 years) El Paso, TX/ Juarez, MX
Public company; contract manufacturer of PCB assemblies and higher-level electro-mechanical assemblies for Class II medical devices for imaging (ultrasound, and X-Ray), telecommunications, consumer electronics, utilities monitoring and automated meter reading; $87 million in sales; 1,200 employees
Managed all QA functions across four focus factories, under my supervision had 13 direct reports, Responsible for ensuring compliance with all applicable internal and external audits, as well as ensure that quality metrics are being monitored regularly across the organization and appropriate corrective steps are taken if quality standards are not being met
•Played lead role in getting, ISO 9001:2000, ISO 13485:2003, TL 9000 release 4 certifications
•Developed and implemented a closed-loop CAPA system
•Coordinated and lead 79 supplier audits; a 38% increase in the number of supplier audits over the previous year
•Reduction of customer complaints by 20%
•Incoming QA 1st pass yields improved from ~ 70% to 92%
• Final QA 1st pass yields improved from ~ 82% to 95% - 100%
•Lead efforts in FTQ (First Time Quality) reductions to improve overall customer experience and operational efficiencies.
Site Quality System Assurance Manager
Public Company; 10,001+ employees; HON; Industrial Automation industry
2003 – 2006 (3 years) Cd. Juarez, MX
Public Company; 1,000 employees; $80 million in sales; manufacturer of electro-mechanical switches and sensors for the four core industry segments: Medical, Aerospace and Defense, Industrial, and Transportation;
Managed all QA functions across two manufacturing sites responsible for leading and standardizing the quality management system to be in compliance with ISO 9001, AS 9000, and ISO/TS 16949,
•Played lead role and successfully implemented and certified the facilities in ISO 900, ISO/TS 16949, and AS 9100
•Led site effort to comply with Boeing, Embraer, BAE Systems, and Caterpillar Quality Management System
•As the company’s primary ISO/TS 16949 trainer, ensured personnel understood critical core requirements and advanced quality tools needed to drive and maintain process improvements
•Incorporated advanced quality tools such as PPAP, APQP, SPC, FMEA, quality function deployment, and the process approach into the quality system
•Develop programs and lead multidiscipline teams to implement site-wide initiatives for Quality Leadership, Analytical Reporting Standardization
•Overseer the supplier quality certification program for over 50 suppliers; in conjunction with the purchasing manager started the supplier partnership process.
•Implemented key measures of quality, slashed customer complaints by 32% to deliver record-setting high in customer satisfaction
•Reduced staffing levels by 10% by re-training 30 operators on proper inspection methods
Public Company; 5001-10,000 employees; Aviation & Aerospace industry
2001 – 2003 (2 years) Chihuahua, MX
Public company; 1,800 employees; $90 million in sales; manufacturer of electrical wiring integrated systems including wire harness assemblies, integration of wiring into electromechanical structures (racks and panels) and electrical cabinets for the aerospace and defense industries
Responsible for leading the quality journey towards AS9100 across two manufacturing sites, Directed, controlled, and staffed the Quality and training departments. Manage 18 Direct Reports.
•Established a robust and independent quality system that ensured compliance with EADS/Airbus, Boeing, Bombardier, Canadair, Dassault, Embraer, Lockheed Martin, and Raytheon Quality Management Systems.
•Successfully transferred 4 assembly lines from Toulouse France.
•Reduced production related issues from70% to less than 20% by timely review and implementation of corrective action.
•Established Quality Control plans for all product lines in manufacturing and provided training, inspection and verification tools as well as scheduled verification audits to ensure product assembly, testing and processes conformed to the Quality Control Plans.
•Established supplier management programs with materials management team to track Quality of products and on-time-delivery performance of various suppliers, as well as a receiving inspection program for incoming materials.
Public Company; 501-1000 employees; NC; Consumer Goods industry
2000 – 2001 (1 year) El Paso, TX/ Cd. Juarez, MX
Public company; 2,000 employees; $80 million sales; manufacturer of consumer home appliances (toasters, iron, ovens, and coffee makers)
Responsible for all quality activities, policies and procedures for two assembly and one injection molding facilities with a staff of 8 quality personnel
•Led project to reduce product quality defects by 70% in 9 months. Through various Process Excellence techniques, root causes for main customer complaints were identified and improvement activities implemented.
•Played lead role and successfully implemented and certified all three facilities in ISO 9002.
•Maintained close interface with customers, sales and marketing, and engineering, to align product quality efforts.
•Established key measurements and improvement plans for all locations.
•Reduced scrap 38% and warranty cost 46% by implementing reliability test, supplier development program, and corrective action / problem solving techniques
Public Company; 201-500 employees; MAG; Electrical/Electronic Manufacturing industry
1998 – 2000 (2 years) El Paso, TX/ Cd. Juarez, MX
Public company; $100 million in sales; manufacturer of residential, commercial and industrial ac/dc electric motors
Responsible for all quality activities, policies and procedures for six motor assembly and component facilities in Mexico with a staff of 8 quality personnel (Six quality managers, one quality system coordinator, one metrology/calibration supervisor). Processes include CNC machining; die casting, winding and assembly.
•Ensured product conformance to engineering and customer specification by implementation and maintenance of quality policies and procedures including new supplier quality program, and calibration program.
•Successfully managed the implementation of quality programs at two start-up plants.
•Transferred six distinct product lines from US operations in a 12 month period.
•Decreased line rejection rate by 30% using first passed yield, while throughput increased 43%.
•Reduced customer complaints by 30% from previous year, resulting in 99.7% accuracy of shipments.
Quality Assurance Manager
Outboard Marine Corp
1994 – 1998 (4 years) El Paso, TX/ Cd. Juarez, MX
Public company; 1,500 employees; $75 million in sales; manufacturer of parts and accessories for outboard marine motors and boats (fuel/oil systems, wire harnesses, gauges and instruments)
Responsible for developing and establishing the quality system for two manufacturing facilities, processes included CNC machining, assembly of fuel and oil systems, wire harnesses, stators and timer base, gages and instruments and finishing operations.\
•Started up electronics (SMT) and assembly work transferred from U.S. plants, double production lines within 6 months
•Electronic Fuel Injection (EFI) was introduced on select OMC drive systems in 1994, representing the first time that EFI was available to recreational stern drive customers
•Recipient of the “OMC Chairman's Award for Team Work” for the launch of the fuel injected motor (FICHT) in 1996 to meet stiffer EPA guidelines
•Conducted through process evaluation to identify and correct series of issues across training, methodology and assembly operations.
•Improved on time delivery from 85% to 99.8% in a 12-month period
•Cut scrap cost per earned standard hour from $1.60 to $0.30 in a 24-month period.
Site Quality Manager
Public Company; 10,001+ employees; MMM; Mechanical or Industrial Engineering industry
1990 – January 1994 (4 years) Cd. Juarez, MX
Public Company; 1,000 employees; $95 million in sales; manufacturer of class I, and II medical devices (disposable skin staplers, surgical drapes, gastrointestinal staplers), industrial abrasives, anti-static devices (wrist bands, cords, mats), data storage (3½ diskettes), and computer interconnecting cables, tapes and adhesives
Managed all QA functions across five focus factories, supervised a staff of 8 quality personnel (4 quality engineers, 1 Calibration Supervisor, 1 Incoming Inspection Supervisor, 1 ISO Coordinator, and 1 assistant). Responsible for implementing the quality program throughout the site, member of the corporate team to perform FDA / GMP audits to the Latin American 3M facilities. Directly interfaced with FDA and Department of Defense (DOD)
•Played lead role and successfully implemented and certified all focus factories in ISO 9002:1987
•By adding safety to the quality planning the site achieved four million man-hours without any lost-time
•Recipient of the “3M Individual Quality Achievement Award” which was one of seven awarded throughout the entire corporation in 1993.
•Implemented the use of performance based metrics and a visual factory process enabling top management to understand the level of effectiveness and to drive corrective actions.
•Trained 30+ professional staff and 500 associates in quality systems, tools and methods including ISO internal audits, FMEA, and PPAP as well as Good Manufacturing Practices
Public Company; 201-500 employees; Music industry
1985 – 1990 (5 years) Cd. Juarez, MX
Public Company; 5,000 employees; manufacturer of modules and chassis for color television
Responsible for the quality across three TV chassis assembly lines (picture in picture), conduct new components approval/validation process (pilot runs). Supervised activities of 8 quality technicians, performed failure analysis for the critical components in the TV chassis. Coordinated weekly meeting regarding the problems experienced with the chassis at the TV assembly plant located in Bloomington Indiana.
•CTC 149 Line was awarded as “The best line of the year”
•Reduced 15% by introducing lean techniques in the assembly lines.
Public Company; 5001-10,000 employees; Airlines/Aviation industry
1979 – 1985 (6 years) Mexico City, MX
Public Company; 10,000 employees; Airlines/Aviation industry
Joined Aeromexico as junior quality engineer responsible for capturing data and analyze/troubleshoot electronics and avionics issues encountered by the pilots during flight.
Promoted in 1980 as senior quality engineer responsible to evaluate and initiate non-destructive testing on all Aeromexico aircraft (airframe, structure, landing gears and engines) per FAA regulations and engine and aircraft manufacturers’ specifications.
Level 2 Certified in Eddy Current, Magnetic Particle Inspection, Liquid Penetrating Inspection, Radiographic Testing, and Ultrasonic Testing.
Alejandro R Ferreira's Languages
Alejandro R Ferreira's Skills & Expertise
- ISO 13485
- Supplier Auditing
- Lockheed Martin
- Quality Systems
- Continuous Improvement
- Supplier Quality
- Quality Auditing
- Root Cause Analysis
- Six Sigma
- Manufacturing Management
- Medical Devices
- Manufacturing Operations Management
- Quality System
- Cross-functional Team Leadership
- Operational Excellence
- Quality Assurance
- Lean Manufacturing
- Quality Management
- Value Stream Mapping
- Iso 9000
- Manufacturing Engineering
- Quality Control
- Product Development
- Business Process Improvement
Alejandro R Ferreira's Education
MBA, Business Administration
2003 – 2005
Instituto Politecnico Nacional
BS ECE, Electronics and Communication
1974 – 1978
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