Steve Gompertz
Partner, Operations and Resourcing at QRx Partners- Claim this Profile
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Bio
Evelyn R.
Few people have the opportunity to report to a manager who is also a coach and mentor. I had the pleasure of working reporting to Steve in his capacity as Director of Worldwide Quality, for almost four years at Pelican BioThermal. He’s one of those leaders who constantly encourages team learning, communication and professional growth. His vast knowledge of applicable regulations and standards helped us greatly develop the organization’s Quality Systems. I was particularly impressed by Steve’s ability to handle even the toughest clients and auditors (effortlessly demonstrating the level of compliance of our organization) as well as internal customers difficult to deal with. No matter how tense a meeting was, Steve made sure everyone left with guidance on what the next steps were towards a potential resolution. His capacity to facilitate conflict resolution, paired with his listening skills and broad vision of the Quality team mission and role within the organization, make him an asset to any management and executive team.
Leonard Hannasch
I have had the pleasure of working under Steve's leadership as Sr. Documentation Manager at St. Jude Medical. Steve leads by example. He was able to communicate a clear vision of his expectations for my role as Manager of CAD Service. This extended to division wide platform and systems harmonization. Applying Steve's methods of communication and performance development allowed me to increase my service groups capacity and value to the business.
Jerry Jablonski
Steve is a great manager. He works hard at staying connected to his customers, direct reports and management team. His knowledge of Med Device Quality Systems helped us to improve our documentation system SOPs. He moved quickly after he was hired and got control of a record retention mess which resulted from site mergers and closings. He is very systematic in his approach to problem solving and project management.
Evelyn R.
Few people have the opportunity to report to a manager who is also a coach and mentor. I had the pleasure of working reporting to Steve in his capacity as Director of Worldwide Quality, for almost four years at Pelican BioThermal. He’s one of those leaders who constantly encourages team learning, communication and professional growth. His vast knowledge of applicable regulations and standards helped us greatly develop the organization’s Quality Systems. I was particularly impressed by Steve’s ability to handle even the toughest clients and auditors (effortlessly demonstrating the level of compliance of our organization) as well as internal customers difficult to deal with. No matter how tense a meeting was, Steve made sure everyone left with guidance on what the next steps were towards a potential resolution. His capacity to facilitate conflict resolution, paired with his listening skills and broad vision of the Quality team mission and role within the organization, make him an asset to any management and executive team.
Leonard Hannasch
I have had the pleasure of working under Steve's leadership as Sr. Documentation Manager at St. Jude Medical. Steve leads by example. He was able to communicate a clear vision of his expectations for my role as Manager of CAD Service. This extended to division wide platform and systems harmonization. Applying Steve's methods of communication and performance development allowed me to increase my service groups capacity and value to the business.
Jerry Jablonski
Steve is a great manager. He works hard at staying connected to his customers, direct reports and management team. His knowledge of Med Device Quality Systems helped us to improve our documentation system SOPs. He moved quickly after he was hired and got control of a record retention mess which resulted from site mergers and closings. He is very systematic in his approach to problem solving and project management.
Evelyn R.
Few people have the opportunity to report to a manager who is also a coach and mentor. I had the pleasure of working reporting to Steve in his capacity as Director of Worldwide Quality, for almost four years at Pelican BioThermal. He’s one of those leaders who constantly encourages team learning, communication and professional growth. His vast knowledge of applicable regulations and standards helped us greatly develop the organization’s Quality Systems. I was particularly impressed by Steve’s ability to handle even the toughest clients and auditors (effortlessly demonstrating the level of compliance of our organization) as well as internal customers difficult to deal with. No matter how tense a meeting was, Steve made sure everyone left with guidance on what the next steps were towards a potential resolution. His capacity to facilitate conflict resolution, paired with his listening skills and broad vision of the Quality team mission and role within the organization, make him an asset to any management and executive team.
Leonard Hannasch
I have had the pleasure of working under Steve's leadership as Sr. Documentation Manager at St. Jude Medical. Steve leads by example. He was able to communicate a clear vision of his expectations for my role as Manager of CAD Service. This extended to division wide platform and systems harmonization. Applying Steve's methods of communication and performance development allowed me to increase my service groups capacity and value to the business.
Jerry Jablonski
Steve is a great manager. He works hard at staying connected to his customers, direct reports and management team. His knowledge of Med Device Quality Systems helped us to improve our documentation system SOPs. He moved quickly after he was hired and got control of a record retention mess which resulted from site mergers and closings. He is very systematic in his approach to problem solving and project management.
Evelyn R.
Few people have the opportunity to report to a manager who is also a coach and mentor. I had the pleasure of working reporting to Steve in his capacity as Director of Worldwide Quality, for almost four years at Pelican BioThermal. He’s one of those leaders who constantly encourages team learning, communication and professional growth. His vast knowledge of applicable regulations and standards helped us greatly develop the organization’s Quality Systems. I was particularly impressed by Steve’s ability to handle even the toughest clients and auditors (effortlessly demonstrating the level of compliance of our organization) as well as internal customers difficult to deal with. No matter how tense a meeting was, Steve made sure everyone left with guidance on what the next steps were towards a potential resolution. His capacity to facilitate conflict resolution, paired with his listening skills and broad vision of the Quality team mission and role within the organization, make him an asset to any management and executive team.
Leonard Hannasch
I have had the pleasure of working under Steve's leadership as Sr. Documentation Manager at St. Jude Medical. Steve leads by example. He was able to communicate a clear vision of his expectations for my role as Manager of CAD Service. This extended to division wide platform and systems harmonization. Applying Steve's methods of communication and performance development allowed me to increase my service groups capacity and value to the business.
Jerry Jablonski
Steve is a great manager. He works hard at staying connected to his customers, direct reports and management team. His knowledge of Med Device Quality Systems helped us to improve our documentation system SOPs. He moved quickly after he was hired and got control of a record retention mess which resulted from site mergers and closings. He is very systematic in his approach to problem solving and project management.
Credentials
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ASQ Certified Medical Device Auditor
ASQ - World HeadquartersMar, 2006- Nov, 2024 -
Certified Manager of Quality / Organizational Excellence (CMQ/OE)
ASQ - World Headquarters -
Certified Medical Device Auditor (CMDA)
ASQ - World Headquarters -
Configuration Management II Certification (CMIIC)
The Institute for Process Excellence -
EU MDR Auditor Certification
Exemplar Global, Inc. -
MDSAP Auditor Certification
Exemplar Global, Inc. -
Project Management Certificate
International Institute for Learning -
Regulatory Affairs Certification (RAC-US)
Regulatory Affairs Professionals Society (RAPS)
Experience
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QRx Partners
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Partner, Operations and Resourcing
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Jun 2020 - Present
Providing consulting expertise from over two decades of medical device industry experience to help companies realize business value as well as compliance from their quality systems. Services Offered: • Quality System Assessment • Audit Preparation • Quality System Development/Remediation • SOP & Forms Development • Regulatory Body Response Guidance • Quality Systems Education See Projects section below for examples of projects undertaken for clients. Providing consulting expertise from over two decades of medical device industry experience to help companies realize business value as well as compliance from their quality systems. Services Offered: • Quality System Assessment • Audit Preparation • Quality System Development/Remediation • SOP & Forms Development • Regulatory Body Response Guidance • Quality Systems Education See Projects section below for examples of projects undertaken for clients.
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St. Cloud State University
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United States
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Higher Education
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700 & Above Employee
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Adjunct Instructor
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Aug 2012 - Present
- Provided consulting on development of the Master of Science in Medical Technology Quality (MS-MTQ) degree program - Developed and now teaching courses for the MS-MTQ program in Quality Systems, Quality & Regulatory Fundamentals, Risk Management, CAPA, and Design Controls - Provided consulting on development of the Master of Science in Medical Technology Quality (MS-MTQ) degree program - Developed and now teaching courses for the MS-MTQ program in Quality Systems, Quality & Regulatory Fundamentals, Risk Management, CAPA, and Design Controls
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Quality Management Systems Potential LLC
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United States
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Business Consulting and Services
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President
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Jun 2008 - May 2020
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Peli BioThermal
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United States
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Packaging and Containers Manufacturing
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100 - 200 Employee
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Director of Worldwide Quality
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Apr 2014 - Mar 2018
Led and managed all quality activities at U.S. and UK sites for a leading provider of passive thermal protection packaging solutions and services for the pharmaceutical, biologics, tissue, blood, and other industries requiring safe transport of temperature sensitive payloads. Led and managed all quality activities at U.S. and UK sites for a leading provider of passive thermal protection packaging solutions and services for the pharmaceutical, biologics, tissue, blood, and other industries requiring safe transport of temperature sensitive payloads.
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St. Jude Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Sr. Manager, Documentation Services
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Apr 2010 - Nov 2012
- Lead the successful integration of document control, CAD services, labeling, and technical writing functions from multiple acquisitions into a division-wide resource driving standardization, seamless collaboration, and best practices across sites in three U.S. locations, Costa Rica, and Israel. - Managed the roll-out of standard document and records control processes and a product lifecycle management system (Windchill) at all division locations. - Developed and delivered a Quality System curriculum to improve understanding by all existing division employees, establish a solid foundation for new employees, and ensure annual refresher training. - Established consistent job descriptions for all roles in my organization, and developed a career development framework matrix and progression chart, to ensure consistent and effective performance management and employee development. Show less
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Canon Medical Informatics
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United States
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Software Development
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200 - 300 Employee
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Quality Systems Manager
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Jul 2006 - Apr 2010
- Leading the expansion, improvement, and implementation of the quality system for an industry leading medical imaging software company to ensure continued effectiveness during globalization, business model evolution, and increasing regulatory scrutiny. - Designated Management Representative for interactions with FDA, notified body, and other regulatory agency inspectors. - Re-wrote company Quality Manual, designed a structured documentation architecture, and mapped entire the quality system to the architecture. - Redesigned Document Control and CAPA processes, integrated Complaint, Hazard Review, and Design Change processes, and formalized Quality Planning, Management Review, and Data Analysis process interactions. - Developed an executive-team approved Compliance Master Plan leveraging a risk-based capability maturity model to assess quality system effectiveness and improvement. - Lead design and implementation of a more effective product development process incorporating agile software development methods while ensuring efficient compliance with regulatory requirements. - Facilitated design and implementation of a broad product life-cycle risk management process. - Responsible for development and delivery of quality systems process training to all employees. - Provide independent review of all risk assessments, design reviews, and development phase closeouts. - Oversee planning and execution of internal audit program. - Participate in and provide support for development of 510(k), Technical File, and other regulatory submission documentation. Show less
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Boston Scientific
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Internal Audit Manager
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Nov 2005 - Jul 2006
- Promoted after 7 months to lead and re-engineer the internal audit function.- Developed a risk-based quantitative model for quality system effectiveness evaluation.- Introduced a tiered supplemental internal auditor training program to enable broader and deeper internal audits.- Provided expertise in design-control process assessment for a $27B merger due-diligence initiative.
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Principal Quality Systems Engineer
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Mar 2005 - Oct 2005
- Guided projects focused on implementing harmonized quality, business, functional, and production processes across multiple domestic and international manufacturing sites.- Lead site and plant quality system certification to ISO 13485.
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Medtronic
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Configuration Assurance Manager
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Aug 2000 - Mar 2005
- Lead an organization responsible for assuring Design History File (DHF), Device Master Record (DMR), and Quality System processes and records compliance for a multi-billion dollar business unit with multiple international divisions and sites.- Turned a low-performing organization into a high performing set of teams providing consultation on best practices for configuration management, design documentation, and regulatory compliance.- Consulted on redesigning and aligning the quality systems used by ten divisions and facilities into a unified business-unit quality system. Show less
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Sr. Mfg. Business Systems Project Leader
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Jul 1995 - Jul 2000
- Managed process optimization, standardization, and systems implementation initiatives in Manufacturing Engineering, Receiving/Inspection, Material Planning, and Production operations.- Developed a business case for co-locating final packaging within distribution centers.- Improved the support and enhancement process for a global MRPII system across multiple divisions.- Standardized material acceptance processes across two multi-billion dollar business units.- Successfully turned around a Demand-Flow Manufacturing system project with a history of missing milestones and not meeting customer requirements. Show less
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Mechanical Design Automation Project Leader
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Apr 1991 - Jun 1995
- Developed the vision and strategic direction for leveraging Mechanical CAD (MCAD) technology.- Introduced concurrent engineering concepts that shortened a pilot project by 33%.- Introduced engineering design data exchange methods between internal functions and with external suppliers- Decreased cycle time by reduced drafting content relative to increased digital design information.
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Sr. Applications Analyst - CAD/PDM Systems
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Aug 1990 - May 1991
- Provided external customer consulting on CAD, PDM, and data exchange.- Developed and implemented custom PDM software solutions.- Provided software sales support; identifying requirements for enhancements and corrections.
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Sr. Programmer/Analyst - CAD/PDM Implementation
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Dec 1986 - Jul 1990
- Implemented a cross-functional document control system enabling division-wide collaboration - Implemented customized PDM software integrated with CAD applications.
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Programmer/Analyst
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Jan 1984 - Nov 1986
- Designed and developed Solid Modeling CAD and Electrical Design software applications.- Redesigned the user interface of a fading software product to extend its market life.
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Education
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Lehigh University
BSME, Mechanical Engineering -
University of Saint Thomas
Mini-MBA in Medical Technology Management Certificate -
New Milford High School
Community
