Alejandro Hernandez

Experience

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  Panasonic, Matsushita Battery

  Jan 1996 - Jan 1999

  Project Supervisor, MK/QA, New Product Introduction (NPI)

  - New Technology Transfer to Tijuana; trained in Tokyo, Japan (Plant based in Nagoya and Chigasaki City). - Worked with R&D, Engineering and Quality, both, Japan, and Tijuana (Machine Assemble and Installation).- Involved in KAIZEN Projects (Improving our Work, Efficiency and Safety).- Managed a Staff of 11: (4) Technicians and (7) Operators.Quality Management System: - ISO 9001 QMS Requirements.- ISO 14000 Environmental Management.

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  Sharp Electronics

  Jun 1999 - May 2006

  Quality Engineer (QE)

  Quality System Regulations; American Regulations (UL, DHHS, FDA, FCC Part 15).- Managed Quality System Regulations External/Internal Audits based on Regulation Guidelines and Requirements. . Calibration System: Operation and Control Management.- Managed the Equipment Control System (Three “3” divisions +1,000 Equipment). - Successfully established the Calibration Laboratory (Operations started in June of 2004) with annual savings of $10,000 USD; further investments were planned to increase capabilities.Revolution, Creative Action Teams (R-CATS) Corporate, Global Program Lead Coordinator (2003:2006). (Pan-Atlantic Convention formed by the USA, Mexico, Spain, UK, France, Germany).- Lead Coordinator for R-CATS managed more than 20 KAIZEN Projects with Annual savings of $500,000 USD.- Coordinated the Winner Teams Awarded in 2004 (Osaka, Japan) and 2005 (Barcelona, Spain).Service and Support Group (SSG):- In charge for the Monthly Quality Meetings, Customer Complaints both North America and Latin America. Quality Management System: - ISO 9001 QMS Requirements | Internal Auditor.- ISO 14000 Environmental Management.- Quality System Regulations (UL, DHHS, FDA, FCC Part 15). Show less

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  KAMIMEX SA DE CV

  May 2006 - Jul 2008

  Quality Engineer (QE)

  - Appointed as Management Representative under ISO9001 clause 5.5.2. Responsible to Coordinate Internal and External Audits (i.e. Certification Body & Customers). - Direct communication with VP, Japan (HQ), Chicago Sales Operations and Suppliers. -Responsible for the Monthly Quality Meetings, Management Review Meeting, Internal Audits, Document Control, CAPA, Calibration, MRB, PPAP Submission and the IMDS / Environmental. -Managed a Staff of 5: (1) Lead, (1) Document Control Assistance, (1) Technician and (2) Inspectors.Quality Management System: - ISO 9001 QMS Requirements.- Management Review Meetings (MRM).- Document Control System.- Corrective and Preventive Action (CAPA) System. - During Certification Body Assessments; Active Member of the Inspection Room (a.k.a. Front Room) as Lead Guide, Subject Matter Expert (SME) and English Language Support Translator. Show less

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  Covidien (Medtronic Minimally Invasive Therapies Group)

  Jun 2009 - Jun 2015

  Quality Plant Supervisor

  Supplier Quality Assurance (SQA) // Supplier Quality Engineer. - Performed Supplier Audits (Mexico, USA, and Canada) certified under the corporate guidelines for Internal Lead Auditors to standards and regulations (ISO13485, CFR part 820, CMDR, JPAL, ANVISA, MDD).- Worked directly with Corporate R&D, Engineering, Quality, and Sourcing improving and aligning Component Specifications with Suppliers. Quality Assurance // Incoming Inspection for Raw Material. - Managed Incoming Inspection for 5 divisions (Urology, Suction, OR, Devon, Molding), providing Service & Support.- Monitored the Quality and Performance of Suppliers with +5,000 Raw Material Purchase Specifications (RMPS).- Managed the Part Certification Program (Ship-To-Stock) Improved from 19% to 50%. I was incorporating more than 2,500 part numbers into the STS program. - Managed a Business Strategy to control the Plant MRB System with Sourcing, Suppliers, Corporate, and Finance.- Managed a Staff of 21: (4) Lead Monitors, (9) Inspectors and (8) Operators.Quality Management System:- ISO 13485 Medical Devices. - Quality System Regulations (FDA 21 CFR Part 820, CMDR, JPAL, ANVISA, MDD).- Certified Internal Lead Auditor. - During Certification Body Assessments; Active Member of the Inspection Room (a.k.a. Front Room) as Scriber, Subject Matter Expert (SME), and English Language Support Translator. Show less

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  Haemonetics

  Jun 2015 - Jul 2016

  Supplier Quality Systems Engineer (SQSE)

  - Managed Incoming Inspection for 2 divisions/buildings, providing Service & Support.- Monitored the Quality and Performance of Suppliers with +1,000 Raw Material Specifications (RMS).- Managed the Plant MRB System; eliminating $1MM of aged inventory reaching control and a Healthy System.- Build Business Strategy to align Component Specifications (Suppliers, Corporate, Engineering, Sourcing, Finance).- Managed a Staff of 5: (1) Lead, (2) Inspectors (2) Operators.Quality Management System:- ISO 13485 Medical Devices.- Quality System Regulations (FDA 21 CFR Part 820, CMDR, JPAL, ANVISA, MDD).- During Certification Body Assessments; Active Member of the Inspection Room (a.k.a. Front Room) as Scriber, Subject Matter Expert (SME) and English Language Support Translator. Show less

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  Flex

  Jul 2016 - Aug 2017

  Senior Supplier Quality Engineer (Sr. SQE)

  - Managed Customers Accounts (Bracco, Stryker, Ethicon/J&J). - Strengthened business relation to align Component Specifications (Suppliers/Customer, Engineering, Sourcing).- Performed Supplier Audits (Mexico and USA) certified under the corporate guidelines for Internal Lead Auditors to Standards and Regulations (ISO13485, CFR part 820, CMDR, JPAL, ANVISA).- Monitored the Quality and Performance of Suppliers with +300 Raw Material Specifications (RMS).- Managed Supplier Qualification, Quality Plan, Risk Assessment, Standard and Regulatory Requirements, Supplier Agreements and Supplier Monitoring. Show less

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  Nypro, A Jabil Company

  Aug 2017 - Jan 2019

  Senior Supplier Quality Engineer for NPI (New Product Introduction)

  Corporate Level Position:- Managed the Medtronic Account (5 NPI Projects, 5 Sustaining, and 1 Cost Reduction Project).- NPI: Worked directly with the Customer and Nypro Business Unit Representatives (Management, Engineering, Quality, Sourcing and Materials). Customer Requirements, Part Qualification through PPAP (Control Plan, FMEA, MSA, SPC), Supplier Qualification, Risk Assessment, Supplier Agreements, and Supplier Audits. - Sustaining: Worked to establish a business relationship to align Component Specifications (Suppliers/Customers).- Cost Reduction Program: Part Qualification through Customer Requirements and Technical Review with Suppliers. Show less

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  Smiths Medical

  Jan 2019 - now

  ICU MedicalGlobal Supplier Quality (GSQ) Corporate Level Position:- Responsible for Managing Global Supplier Audits (On-Site, Virtual/Remote & Desktop Audits), Execute activities associated with the Management of Supplier and TPM assessments, including Assessment Plans, Execution, Report and Communication of Risk, Corrective Action Approval, and Assessment Closure.- Responsible for engaging with all functional areas to ensure that Supplier and Third-Party Manufacturers (TPM) meet Industry and ICU Medical Requirements/Standards.- Supports Continuous Improvement Projects and initiatives at the Corporate Level. Show less Smiths MedicalCorporate Level Position:Supplier Quality / Supplier Audits:- Maintaining Audit Calendar, Executing Supplier Audits, and Generating Audit Reports.- Providing Support to Suppliers on Failure Investigation and Ensuring the Effectiveness of Corrective Actions.Supplier Quality / Projects: - Managed Smiths Medical Supplier Evaluation and Component Qualification, Supplier Change Request (SCR), Advanced Quality Planning, Article Quality Assessment (AQA), Control Plan, FMEA, MSA, SPC, Supplier Validation Protocols (IQ, OQ, PQ), Global Approved Supplier List (GASL), Risk Management, Supplier Agreements.- Ensure Execution of Supplier Audits within the Required Project Phase.- Prioritize and Effectively Manage Multiple Assignments/Projects in Collaboration with Cross-functional Regulatory, Engineering, Sourcing, and Operational Teams.Supplier Quality / Sustaining (Incoming Inspection & Manufacturing Process):- Responsible for Lead Supplier Non-conformance detections within the Manufacturing Process and Incoming Inspection. Non-conformance Handling, Failure Investigation, and Material Review Board (MRB) support.- Work in a Teamwork Environment with Suppliers and Operations Representatives to align Component Specifications (Management, Engineering, Quality, Sourcing, Materials, and Operations). Show less

  • Supplier Quality Senior Auditor

    Dec 2022 - now

  • Senior Supplier Compliance Engineer (Sr. SCE)

    Feb 2020 - Nov 2022

  • Senior Supplier Quality Engineer (Sr. SQE)

    Jan 2019 - Jan 2020