Steve Gompertz

Andover, Minnesota, United States Contact Info
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    Management Consulting and Change Management

About

Steve Gompertz is a leader in Quality Systems management. His career includes roles in…

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Experience & Education

  • QRx Partners

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Licenses & Certifications

Volunteer Experience

  • President & Boys Basketball Director

    Andover Athletic Association

    - 16 years

    Children

  • YMCA of the Greater Twin Cities Graphic

    Andover Community Management Board Founder

    YMCA of the Greater Twin Cities

    - 1 year

    Social Services

Publications

  • Quality System Maturity: Applying Risk Management & CMMI Concepts to Quality System Evaluation

    Biomedical Focus 2007 Conference Proceedings

  • Product Data Management the Second Time Around

    CMII 2001 Conference Proceedings

  • Initial Graphics Exchange Specification (IGES): Case Studies & Their Value to the Exchange Process

    National IGES User Group 1994 Conference Proceedings

  • Fundamentals of IGES Testing and Debugging

    AUTOFACT 1993 Conference Proceedings

Projects

  • QS Education & Process Improvement

    - Present

    Developing and delivering employee education on QS basics and CAPA, and providing guidance on improving the Supplier Management process.

  • ISO 13485 Certification Pre-Audit & Remediation Planning

    Provided ISO-13485 audit and implementation guidance to a small precision component supplier in preparation for pursuing medical device customers.

  • Quality System Documentation Review

    Provided independent review of quality system process implementation and documentation for a medical device startup.

  • Quality System Implementation

    Created a quality system and provided training for an early-stage medical device company developing neurological diagnosis software.

  • QS Harmonization

    -

    Harmonizing the quality management systems at 13 medical device development and manufacturing sites.

  • QS Process Documentation

    -

    Providing guidance on updating QS documentation in preparation for compliance with ISO 13485:2016, and implementation of new ERP, PLM, and eQMS tools.

  • AS9100C SOP Improvement

    -

    Created and re-wrote procedures, forms, and templates to improve quality system effectiveness and compliance for a mid-size aerospace products manufacturer.

Honors & Awards

  • SQA Distinguished Speaker

    Society of Quality Assurance (SQA)

    The Society of Quality Assurance Learning Foundation (SQA-LF) has established a Distinguished Speaker program that identifies and recognizes the top-rated SQA speakers each year. Individuals who are invited to join the Distinguished Speaker Inventory are experts on a wide variety of Quality Assurance (QA) topics, and they have demonstrated their skill in presenting to audiences in a meaningful and engaging way. A current list of Distinguished Speakers is below.

  • Charles W. Britzius Distinguished Engineer Award

    Minnesota Federation of Engineering, Science and Technology Societies

    Recognized for outstanding leadership in, contributions to, and dedication to advancing the knowledge of Quality Engineers, Quality professionals, and others employed in the medical technology industry over 3 decades through development of innovative training materials and programs, presenting to peers at industry and professional organization events, development of a unique master’s degree program, and maintaining a presence in professional media platforms.

  • Blue Ribbon - Barbeque Sauce - 2014 MN State Fair

    -

  • Boston Scientific Cardiovascular Operations StAR Award

    -

    Recognized for exceptional project management in picking up a stalled project to prepare the manufacturing site for ISO 13485 certification with just 4 months left until the scheduled notified body inspection. Certification was achieved with the inspection producing no nonconformity observations.

  • Medtronic CRM Technical Leadership Excellence Award nominee

    -

  • Medtronic Individual Performance Program Award

    -

  • Vital Images Top 10% Performance Award

    -

Organizations

  • Society of Quality Assurance

    -

    - Present

  • American Society for Quality (ASQ)

    -

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