Ernie Tursich
Principal Quality and Regulatory Affairs Specialist at Medibio Limited- Claim this Profile
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Bio
Brian Lawrence
I've worked with Ernie for more than ten years and during that time I've come to value Ernie's contributions to the team. On the software projects I've lead, I've asked for Ernie to lead the verification team. I know that Ernie will deliver a super high quality product, he will deliver it on time, he is a team player, and great to work with. I can ask Ernie to lead the Verification team and he pretty much takes care of the rest.
Thomas Doyle
I worked with Ernie for over 4 years at Smiths-Medical on several different projects. He is always very easy to talk with. He is always interested in hearing about problems, and is always willing to help investigate possible issues. He encourages others to push themselves. He works tirelessly to meet company deadlines. He has incredible product knowledge. He is kind, diligent, thorough, adept… I highly value his input. He is an excellent team lead, and I would love to work for him again.
Brian Lawrence
I've worked with Ernie for more than ten years and during that time I've come to value Ernie's contributions to the team. On the software projects I've lead, I've asked for Ernie to lead the verification team. I know that Ernie will deliver a super high quality product, he will deliver it on time, he is a team player, and great to work with. I can ask Ernie to lead the Verification team and he pretty much takes care of the rest.
Thomas Doyle
I worked with Ernie for over 4 years at Smiths-Medical on several different projects. He is always very easy to talk with. He is always interested in hearing about problems, and is always willing to help investigate possible issues. He encourages others to push themselves. He works tirelessly to meet company deadlines. He has incredible product knowledge. He is kind, diligent, thorough, adept… I highly value his input. He is an excellent team lead, and I would love to work for him again.
Brian Lawrence
I've worked with Ernie for more than ten years and during that time I've come to value Ernie's contributions to the team. On the software projects I've lead, I've asked for Ernie to lead the verification team. I know that Ernie will deliver a super high quality product, he will deliver it on time, he is a team player, and great to work with. I can ask Ernie to lead the Verification team and he pretty much takes care of the rest.
Thomas Doyle
I worked with Ernie for over 4 years at Smiths-Medical on several different projects. He is always very easy to talk with. He is always interested in hearing about problems, and is always willing to help investigate possible issues. He encourages others to push themselves. He works tirelessly to meet company deadlines. He has incredible product knowledge. He is kind, diligent, thorough, adept… I highly value his input. He is an excellent team lead, and I would love to work for him again.
Brian Lawrence
I've worked with Ernie for more than ten years and during that time I've come to value Ernie's contributions to the team. On the software projects I've lead, I've asked for Ernie to lead the verification team. I know that Ernie will deliver a super high quality product, he will deliver it on time, he is a team player, and great to work with. I can ask Ernie to lead the Verification team and he pretty much takes care of the rest.
Thomas Doyle
I worked with Ernie for over 4 years at Smiths-Medical on several different projects. He is always very easy to talk with. He is always interested in hearing about problems, and is always willing to help investigate possible issues. He encourages others to push themselves. He works tirelessly to meet company deadlines. He has incredible product knowledge. He is kind, diligent, thorough, adept… I highly value his input. He is an excellent team lead, and I would love to work for him again.
Experience
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Medibio Limited
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Australia
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Mental Health Care
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1 - 100 Employee
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Principal Quality and Regulatory Affairs Specialist
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Jul 2018 - Present
* Design Assurance - review/approve critical product documents * Quality System - develop quality system procedures, train co-workers, support 13485 audits. * Regulatory - prepare documents for regulatory submissions * Data Privacy and Security Officer - develop and support 27001, HIPAA, and GDPR compliance * Design Assurance - review/approve critical product documents * Quality System - develop quality system procedures, train co-workers, support 13485 audits. * Regulatory - prepare documents for regulatory submissions * Data Privacy and Security Officer - develop and support 27001, HIPAA, and GDPR compliance
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Insight Global working at Baxter
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Brooklyn Park, MN
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Consultant
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Dec 2017 - Jun 2018
* Led validation of off-the-shelf software tools. * Prepared software verification reports. * Led validation of off-the-shelf software tools. * Prepared software verification reports.
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Smiths Medical
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United States
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Medical Device
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700 & Above Employee
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Principal Software Engineer
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Feb 2005 - Oct 2017
Lead a team of Test Engineers in validating the software in a medical products. Tasks include: * Validate medical products for safety and efficacy, ensuring that products meet their user needs and requirements, and that risks are mitigated. * Validate network-connected medical products for security. * Ensure that products are developed in conformance with 21 CFR 820, 62304, 82304, 14971, 13485, and other standards and guidances. * Identify product stakeholders and their use cases across the lifecycle of the product. * Mentor and train co-workers for the roles of Software Test Lead and Software Tester. * Formally execute the test procedures. These become part of the test record of the product and part of the 510(k) submission to the FDA. * Create test reports which document why the medical product is deemed safe and effective. This too becomes part of the filing with the FDA. * Safety Team officer and member of Incident Investigation Task Force, Bylaws Task Force, Training Task Force, Corrective Action Tracker Task Force, and Long Term Planning Task Force. Among the products validated for Smiths are: * CADD-MS 3 * Cozmo Insulin Pump * Medfusion 3500 Infusion Pump * Medfusion 4000 Infusion Pump * CADD-Solis HPCA Ambulatory Infusion Pump * CADD-Solis VIP Infusion Pump * CADD-Prizm Infusion Pump * CADD-Legacy Infusion Pump * SpectrO2/LOGIX Show less
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Meridian Technology Group
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United States
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Information Technology & Services
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1 - 100 Employee
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Software Engineering Consultant
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Aug 2003 - Feb 2005
* Systems Integrator on the power grid control system. * Application Programmer connecting PacifiCorp specific applications to the power grid control system, using Visual Basic, Visual C++, Ruby, and VB Script. * Systems Integrator on the power grid control system. * Application Programmer connecting PacifiCorp specific applications to the power grid control system, using Visual Basic, Visual C++, Ruby, and VB Script.
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Siemens Energy, f.k.a. Control Data - EMSD
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Greater Minneapolis-St. Paul Area
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Lead Software Engineer
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Oct 1980 - Oct 2001
Systems Integrator on Taiwan Power project - built and maintained both development and validation test Energy Management Systems (EMS), led Factory Acceptance Testing of the EMS, automated the systems build process, integrated new applications into the EMS, and identified and rectified system performance issues. Software Development Lead for various products on various Energy Management Systems, programmed in Visual C++, Visual Basic, C++, C, Fortran, Pascal, Assembler, and Unix scripts: * Data Acquisition - retrieving data losslessly from remote terminal units. * Alarm Display and Control - directs processing of alarms and ensures that alarms cannot be lost. * Event Message Processor - creates databases and reports for events on the EMS. * Real Time Sequence - maintains correct sequential operation of multiple network analysis apps. * Network Connectivity Analysis - visual display of the power grid integrity. * Inter-System Data Transfer - lossless transfers of data between customer systems and the EMS. Show less
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Education
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2014 - 2017
St. Cloud State University
Master of Science - MS, Regulatory Affairs and Services -
1974 - 1977
St. Olaf College
Bachelor's degree, Mathematics and Sociology, minor in Economics
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