Supplier Quality Management
2012 to Present
Tucson, Arizona Area
Supplier Quality Management
July 2011 to December 2012
Plant Quality Manager
2010 to 2011
CTS Electronics Manufacturing Solutions
Principal Quality Engineer (Medical Applications)
2009 to 2010
Tucson, Arizona Area
Kimberly-Clark, Health Care
Quality & Validation Process.
2007 to 2009
Becton Dickinson Medical
Quality Management System & CAPA.
2000 to 2007
Master’s Degree Quality & Regulatory with emphasis in Medical Devices Technology Leadership and Innovation
ARIZONA STATE UNIVERSITY, Ira A. Fulton Schools of Engineering
Six Sigma Black Belt Statistics process control Certificate
Instituto Tecnologico y de Estudios Superiores de Monterrey
Master Degree Engineering Quality System and Manufacturing Master Science
2001 to 2005
University of Chihuahua
Master of Business Administration Quality Management Systems MBA
1998 to 2000
ITH Institute Technologic of Hermosillo
Mechanical Engineer Mechanical Engineering Bachelor
1988 to 1993
Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Responsible for the development, establishment, and maintenance of all aspects of the Supplier Quality Assurance and Receiving Inspection programs, policies, processes and procedures. Enhanced Ventana Parts Approval Process (VPAP), which requires all critical supplied parts to meet established performance... Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Responsible for the development, establishment, and maintenance of all aspects of the Supplier Quality Assurance and Receiving Inspection programs, policies, processes and procedures. Enhanced Ventana Parts Approval Process (VPAP), which requires all critical supplied parts to meet established performance specifications, provides additional assurance that we’re designing and producing the highest quality products for our customers.
What company does Daniel MBA. work for?
Daniel MBA. works for Roche Group
What is Daniel MBA.'s role at Roche Group?
Daniel MBA. is Supplier Quality Management
What industry does Daniel MBA. work in?
Daniel MBA. works in the Medical Devices industry.
Quality Assurance & Validation professional with a Mechanic Engineering degree, experience on manufacturing with a ASQ Certified Quality Engineer and ASU Six Sigma Black Belt Certification, using analytical and leadership skills to provide immediate results in process in a medical background, hands on in Quality dedicated and supplier audit activities, RABQSA lead auditor ISO 13485; areas of experience include: Knowledge in QA regulatory 21 CFR part 820, ISO13485, 2003 responsible for process from disciplined requirement reviews through highly standardized IQ/OQ/PQ validation protocols, experience with Class I, II and III Medical Devices. Medical applications includes: Wire cables, electronic assemblies, machining, plastic/silicon molding, extrusion, PCB board assembly, metal stamping, powder coating, plating and silkscreen. Extensive experience with a failure reporting, analysis and corrective action system (FRACAS) for reporting, classifying, analyzing failures, and planning corrective actions in response to failures. CMM Programming, using PC-DMIS Software and GD&T (Geometric dimensioning and tolerance). ASME Y14.5M-1994 . Specialties: Product performance and reliability. 1.Focus on improving Right the First Time (RFT) production rates, 2.Reducing Out of Box Failure (OOBF) rates, 3.Improve design for quality and manufacturability (DQM), 4.Monitoring critical performance indicators for all new pipeline products, 5.Improved Risk Management process.Supplier Quality Management @ Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Responsible for the development, establishment, and maintenance of all aspects of the Supplier Quality Assurance and Receiving Inspection programs, policies, processes and procedures. Enhanced Ventana Parts Approval Process (VPAP), which requires all critical supplied parts to meet established performance specifications, provides additional assurance that we’re designing and producing the highest quality products for our customers. From 2012 to Present (3 years) Tucson, Arizona AreaSupplier Quality Management @ Thoratec is the world leader in mechanical circulatory support with the broadest product portfolio to treat the full range of clinical needs for advanced heart failure patients, PVAD™(Paracorporeal Ventricular Assist Device), IVAD™(Implantable Ventricular Assist), HeartMate® I (XVE) LVAS (Left Ventricular Assist System) and CentriMag® Blood Pump. Responsible for conducting key objectives of the Supplier Quality Management program. Helps establish, implement and maintain a quality audit program that verifies Thoratec supplier quality management systems are in compliance with 21 CFR Part 820, Good Manufacturing Practices, and international standards and requirements, such as ISO 13485, Medical Device Directives, Active Implantable Medical Device Directives, and Canadian Medical Device Regulations. Oversees various supplier quality management activities. Supports the supplier quality system to achieve high levels of efficiency, quality, and cost savings. From July 2011 to December 2012 (1 year 6 months) Plant Quality Manager @ Alphaprotech developing, manufacturing and marketing a line of high-value protective apparel, infection control and extended care products; these products are classified into three business segments. Protective Apparel featuring a complete head to toe protective apparel line, consisting of shoe covers, coveralls, bouffant caps, gowns, frocks and lab coats; Infection Control consisting of a full line of face masks, eye shields. Responsible to develop processes and systems that ensure the quality, reliability and safety of procured products and services. Duties include supervision of assigned personnel, allocation of resources, adherence to applicable quality assurance and customer requirements, participation / providing leadership in continuous improvement activities, and training of personnel when required. supplier selection / approval processes, and supplier improvement programs that include statistical and advanced quality planning techniques. From 2010 to 2011 (1 year) Principal Quality Engineer (Medical Applications) @ CTS Corporation design and manufacturer of a diverse array of electronic components and sensors, and provider of EMS products and services for the medical sector. Responsible to coordinate and maintains the site quality system, specifically the internal audit, the preventive and corrective action program and the document control function responsible for the compilation, analysis and presentation of quality data and reports. Mentor and coach peers and subordinates in continuous improvement process. From 2009 to 2010 (1 year) Tucson, Arizona AreaQuality & Validation Process. @ Kimberly-Clark Health Care manufactures and markets digestive health, closed suction systems, oral care products, surgical drapes, gowns, sterilization wrap and pouches, gloves, personal protective apparel, face masks, and patient care products. Responsible for products included Class I, Class II, and active medical devices, non-invasive, invasive, validation coordinator for relocation of over 60 injection molding machines producing components for medical devices; leading four teams by providing direction and guidance to successfully complete the required 250 + validations. From 2007 to 2009 (2 years) Quality Management System & CAPA. @ BD Medical manufactures and market needles, syringes and intravenous catheters for medication delivery. Responsible to ensure that we effectively and efficiently meet all business, regulatory, quality and compliance requirements for CAPA’s and Document Management, allow appropriate and immediate trending of key metrics, and provide report to management on a monthly basis. From 2000 to 2007 (7 years) Master’s Degree, Quality & Regulatory with emphasis in Medical Devices, Technology Leadership and Innovation @ Purdue UniversitySix Sigma Black Belt, Statistics process control, Certificate @ ARIZONA STATE UNIVERSITY, Ira A. Fulton Schools of EngineeringMaster Degree, Engineering Quality System and Manufacturing, Master Science @ Instituto Tecnologico y de Estudios Superiores de Monterrey From 2001 to 2005 Master of Business Administration, Quality Management Systems, MBA @ University of Chihuahua From 1998 to 2000 Mechanical Engineer, Mechanical Engineering, Bachelor @ ITH Institute Technologic of Hermosillo From 1988 to 1993 Daniel MBA. is skilled in: ISO 13485, CAPA, V&V, ISO 14971, Part 820, Class III Medical Devices, FDA, Six Sigma, Quality System, Lean Manufacturing, SPC, Quality Auditing, FDA GMP, Classroom Management, Calibration
Extraversion (E), Sensing (S), Thinking (T), Perceiving (P)
2 year(s), 7 month(s)
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