Alfonso Ramirez work email
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Alfonso Ramirez personal email
I am a Senior medical device professional with heavy Quality and Operations experience providing support to all phases of the product life cycle including early development, pilot and high volume production and post market vigilance. I have a strong track record in both early start-up and established companies. I carry extensive experience in establishing, registering, and operating off-shore operations including prolonged ex-patriot assignments in Costa Rica. I am seeking a position in a fast paced Medical Device company which will profit from my +18 years of product development, lean manufacturing and Quality Operations experience. I am adept at leading multidisciplinary teams, managing budgets and supporting quality disciplines. I carry the unique experience in both ramp up and decommissioning of domestic and international manufacturing facilities including clean room design and validation as well as regulatory licensing.Specialties: Medical Device Manufacturing, COG Reduction, Manufacturing Engineering, Outsourcing, CFR21 Experience, ISO 13485 Experience, R&D Design, Advanced Engineering, Off Shore Manufacturing, Clean Room Design and Validation, Process Validation, New product Transfer, and Six Sigma principles.Certified competent communicator by Toastmasters International, Alternative energy certification by the National Alternative Fuel Training Consortium.
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ConsultantRamirez Ventures Inc.United States
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Vice PresidentMercy And Grace Ministries Jan 2024 - Present -
Postgraduate StudentNorthern California Bible College 2022 - PresentPleasanton, California, Us -
Sr. Manager Quality AssuranceStryker Jan 2015 - May 2024Kalamazoo, Mi, Us -
Quality ManagerStryker Jan 2015 - Jan 2015Kalamazoo, Mi, Us
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Director Of ManufacturingCreganna Tactx Medical Sep 2012 - Jul 2014Galway, Co. Galway, Ie• Executed remediation activities for struggling operations• Directed the activities to support manufacturing serving 200 active customers• Assisted raising the quality level of the company thru fundamental GMP training and lean principles• Managed the activities of catheter production, balloon manufacturing, and extrusion• Designed and Developed new line expansions for existing customers by providing production processes for new concept introductions -
Director Of OperationsHourglass Technologies Inc. May 2010 - Aug 2012• Established all manufacturing for a complicated bariatric device including installing a fully operational machine shop, fully outfitted IQC lab, and hiring all operational staff.• Secured FDB License in time to meet clinical export requirements• Repaired, commissioned and validated controlled environment rooms (ISO class 7 & 8)• Managed $1.6MM startup budget including facilities, operational human capital, environmental responsibilities, materials and logistics• Increased production thru-put from 1 device every two days to four devices per day.
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PrincipalRamirez Ventures Inc. Jun 2009 - May 2010• Medical Device consulting including Clean Room design and validation• Off-shore manufacturing support including facility tuning and manufacturing engineering• Managed and promoted programs for energy independence and alternative fuel adoption
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Director Of OperationsHologic Aug 2008 - May 2009Marlborough, Ma, Us• Trained international counterparts and multidisciplinary teams for seamless transition of manufacturing operations for a gynecological electromechanical catheter (Class 2 device)• Assisted with quality metrics for manufacturing yield and ISO 13485 and 21CFR compliance• Transferred operations to international site under budget and within the project timeline• Transfer included design of manufacturing layouts, equipment setup and process characterization, installation and operation qualifications as well as establishment of long term process stability• Provided technical support to regulatory and QA for PMA supplements related to the transition• CAPA system overhauled with closure of many corrective actions which were delinquent or under disproportionate extensions -
Director Of OperationsCytyc Surgical Products 2005 - 2008• Designed and validated a class 8 clean room within project timeline and under budget • Performed process characterizations including time studies, capacity studies and process capabilities• Successfully transferred balloon catheter products (Class 2) from R&D to operations including generation of MPIs, process validation, label design and control and First Lot to Stock• Successfully implemented many cost reduction and yield improvement projects using 6 Sigma
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Operations ManagerNovacept Costa Rica S.A. 2000 - 2005• Duplicated and qualified electromechanical catheter manufacturing facility including compliance with foreign regulatory requirements• Designed highly visual manufacturing process instructions in multiple languages • Served as Management Representative during ISO and FDA audits. • Trained an agricultural based workforce into fully qualified medical device operators• Initiated programs such as English as a second language, work cell self-management, six sigma quality programs, and lean manufacturing programs• Reduced COG to under $400 through transfer
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Associate EngineerNovacept 1997 - 2000• Wrote and executed test protocols for Electromechanical device development (Class 2 device)• Designed temperature monitoring array for in vivo clinical data collection• Machined early prototype assemblies using semi-automatic mill, lathe and other shop equipment• Executed Design of Experiment for RF energy density study• Executed Design of Experiment to establish resistance welding process parameters including edge of failure study and gauge R&R on the test measurement system• Contributed to each design review stage providing information on manufacturability, validation and market readiness • Set up and qualified electromechanical catheter manufacturing from scratch including line layout, equipment selection and procurement • Performed installation, operation and process performance qualifications adhering to GHTF standards• Selected and qualified initial suppliers of the early supply chain• Designed and optimized early manufacturing process instructions including training of operators• Trained sales and service staff on technical aspects of the product
Alfonso Ramirez Skills
Alfonso Ramirez Education Details
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University Of PhoenixGlobal Buisness Management
Frequently Asked Questions about Alfonso Ramirez
What company does Alfonso Ramirez work for?
Alfonso Ramirez works for Ramirez Ventures Inc.
What is Alfonso Ramirez's role at the current company?
Alfonso Ramirez's current role is Consultant.
What is Alfonso Ramirez's email address?
Alfonso Ramirez's email address is ra****@****bal.net
What schools did Alfonso Ramirez attend?
Alfonso Ramirez attended University Of Phoenix.
What skills is Alfonso Ramirez known for?
Alfonso Ramirez has skills like Lean Manufacturing, Six Sigma, Manufacturing Engineering, Capa, Medical Devices, Facilities Management, Quality Control, Iso 13485, Clean Rooms, Fda, Design For Manufacturing, R&d.
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