John Czech

Supplier Quality - Component Engineering at Medtronic at Medtronic
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Contact Information
us****@****om
(386) 825-5501
Location
Minneapolis, Minnesota, United States, US

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Xiaoxia Wang

To support CE certification renew, John led a cross-functional project to build the technical documents, as well as the tech-file creation and maintenance procedures. He has in-depth understanding of all the international standards that medical products need to be compliant to, and tons of direct experience on TUV submission and CE-certifying. He has helped us through challenging situations. Really appreciate his consulting work!

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Credentials

  • DRM Green Belt
    Medtronic

Experience

    • United States
    • Technology, Information and Internet
    • 1 - 100 Employee
    • Supplier Quality - Component Engineering at Medtronic
      • 2018 - Present

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Quality Assurance - Component Engineering
      • Oct 2012 - Present

      Sr. Principal Design Technician - Component Engineering: Supplier Validations (IQ, OQ, PQ, MSA/Gage R&R, FIRST Article Inspection), Process Validations, Risk Assessments, Supplier QualificationDRM Green Belt; Statistics for manufacturing processes at suppliers. Developing and sustaining partnerships with suppliers through sound measurement practices, manufacturing controls and leveraging high quality expectations.

    • Quality Engineering - Contractor
      • Jun 2011 - Oct 2012

      Process validation for manufacturing of leads and adaptor components for Medtronic, including DOEs, characterization, IQ, OQ and PQ activities. Also performed Measurement System Analysis, including Gage R&Rs. Statistical analysis using Minitab software.

    • Reliability Engineering Technician
      • 2007 - Jun 2011

      Responded directly to a critical regulatory need by leading a cross-functional team in updating the documentation, testing and labeling to comply with the latest in International Standards requirements and European Medical Device Directives. I directly influenced enabling approximately 100 external medical devices to retain their CE Marking, allowing them to continue to be distributed in multiple geographies. Developed quality procedures (ISO 13485) for the necessary document file creation and planned updates. Drove compliance and safety of design for Clinical Study systems; my efforts specifically identified one system which could have been potentially harmful or deadly to the patients involved, and prevented its release. As Contractor and Employee. Show less

    • Scoutmaster
      • 1990 - Present

      You know how the youth of today are going to be the leaders of tomorrow? I help them achieve this, through the Scouting program and my personal example and guidance. To date, I have helped 13 of my Scouts to achieve the rank of Eagle Scout, and look forward to helping many more. You know how the youth of today are going to be the leaders of tomorrow? I help them achieve this, through the Scouting program and my personal example and guidance. To date, I have helped 13 of my Scouts to achieve the rank of Eagle Scout, and look forward to helping many more.

    • Sr. Engineering Technician
      • 1999 - 2006

      Was given terrific opportunities in circuit design and PCB layout, component qualifications, Design verification and validation for several medical devices. I delivered, on schedule and without errors, enabling design release for several products. Also was vital to the redesign and cost saving of several other products. Was given terrific opportunities in circuit design and PCB layout, component qualifications, Design verification and validation for several medical devices. I delivered, on schedule and without errors, enabling design release for several products. Also was vital to the redesign and cost saving of several other products.

    • Owner, Manager, Consumer Electronics Technician
      • Sep 1988 - Sep 1999

      As small business owner, supervised, trained, and supported several employees for customer relations and repair skills. Created and maintained a budget for business planning and payroll. Developed vendor relationships for supplies and information exchange. Helped to determine component reliability issues for several brand name manufacturers, resulting in at least one modified recall for repairs. As small business owner, supervised, trained, and supported several employees for customer relations and repair skills. Created and maintained a budget for business planning and payroll. Developed vendor relationships for supplies and information exchange. Helped to determine component reliability issues for several brand name manufacturers, resulting in at least one modified recall for repairs.

    • Electronics Technician
      • 1976 - 1985

      Remember that time before everyone had a PC? My work at this company extended through production testing, engineering prototyping and customer service - for video displays for mainframes, terminals and video games. Remember that time before everyone had a PC? My work at this company extended through production testing, engineering prototyping and customer service - for video displays for mainframes, terminals and video games.

Education

  • World College
    BSEE, Electrical Engineering
    2007 - 2014
  • Cleveland Institute of Electronics
    Electronics Technician Certificate, Electronics Technology

Community

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