WHO WE ARE
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MARK SWANSON

Chief Executive Officer  &
Partner

Mark has been a leader in Quality and Regulatory for over 25 years. His career includes roles in quality engineering, design assurance, audit, and quality  management for companies including  St. Jude Medical and Medtronic, and has provided guidance to numerous medical device and pharmaceutical manufacturers of all sizes,. Mark is also an Adjunct Instructor in St. Cloud State University’s M.S. in Medical Technology Quality program.  He holds a B.S. in Electrical Engineering from the Univ. of MN, an MBA from Argosy University, and certifications in quality management, auditing,, and quality engineering..  Mark was also a member of the working groups that developed the most recent updates to ISO 13485, ISO 9001, and ISO 14971, and serves on several AAMI committees.

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STEVE GOMPERTZ

Chief Operating Officer &
Partner

Steve has been a leader in Quality Systems management for 30 years. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including  Pelican Biothermal, St. Jude Medical, Boston Scientific, Medtronic, and Vital Images,. Steve also helped develop and is an Adjunct Instructor in St. Cloud State University’s M.S. in Medical Technology Quality program.  He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, auditing, project management, and configuration management.

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JACKIE TORFIN

Chief Client Officer &

Partner

Jackie has over 30 years experience and deep expertise in quality, regulatory and clinical compliance.  She has served in Senior Global roles for/or consulted with companies including Beckman Coulter, CIMA Labs, PDL BioPharma, Arizant, Heraeus, Boston Scientific, St. Jude Medical, and Tapemark,.   She holds a Bachelor’s Degree in Medical Technology from the University of Minnesota and a Master’s in Leadership from Augsburg College, and is certified as a Quality Auditor through ASQ.  With her scientific background, ability to quickly grasp technical concepts and creatively address challenges based on compliance and business risk, she is skilled at working across functions to obtain optimal business outcomes that also meet regulatory requirements.  Jackie is also an adjunct faculty member in St. Cloud State University’s M.S. in Medical Technology Quality program. .

TEDDY BUGANSKI

Sr. Software Validation Consultant

Teddy has over 30 years’ experience in Software Quality Assurance for device and non-product software testing and software validation.  As a Business owner, Consultant, and Employee my industries experience include Gas/Electric, Medical Device, Pharma, Insurance, Banking, Health Care, Long-term Care, Government Services, Bureau of Criminal Apprehension and Public Health. My responsibilities include working as Test Coordinator, Sr. Quality Assurance, Sr. Software Validation, Sr. Business Analyst, SQA Specialist, Compliance FDA and ISO Analyst, Quality Auditor, Principal Consultant, and Non-Product Software Quality Manager. 

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RON LEANDER

Chief Financial Officer

Leander Limited LLC

As the owner of Leander Limited, Ron is passionate about helping companies grow and brings a lifetime of experience and unique breadth of expertise. Prior to starting his practice, he worked for 3M, Medtronic, Jostens Access Cash International.  Ron  earned a B.S. in Accounting from Minnesota State University, and is  a CPA.

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TOM CHAMBERS

Business Development Director

Tom’s entire career in business development has been guided by a strong focus on client needs and client success. This has led to sales growth and achievement at multiple companies including Compuware and SWAT Solutions. His background encompasses work in multiple industries including graphic arts and software development. For the last 20 years he has been helping clients in medical device companies such as Boston Scientific, Medtronic, and St Jude Medical to achieve success. Tom attended the University of Minnesota and has a Degree in Advertising Illustration from the New England School of Photography. 

MISSY KLOSTER

Recruiting Advisor

MHSK LLC

Missy has over 20 years of full life cycle recruiting experience working with all levels of an organization helping build strong dynamic teams. Missy has a Bachelor's degree in Communication from Concordia College St. Paul and a passion for cultivating lasting relationships with candidates throughout the recruiting process. Missy's overall goal is to make a positive impact with a candidate when helping them find their next role.

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DALE CAUDILL

Sr. Quality Consultant

Dale has over 17 years of experience in the medical device industry with Medtronic, Boston Scientific, Cirtec Medical and Surmodics, supporting multiple therapeutic areas including: cardiac and neuromodulation stimulation, thrombectomy, in-vitro diagnostics, and combination devices.  Dale’s knowledge and experience span the entire product lifecycle; from early concept through post-market support.  He is expert in Quality Systems and Engineering, with emphasis on Operations and Supply Chain.  Dale has experience resolving FDA 483’s, Warning Letters and Consent Decrees.  He is an experienced trainer, having created and delivered training  on the topics of Lean-Six Sigma (he's a Master Black Belt in both DMAIC and DFSS), device compliance, CAPA, and Design of Experiments (DOE).  He holds a B.S. in Mechanical Engineering from the University of Cincinnati and a Master of Engineering Management from St. Cloud State University.

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JANET BAILEY

Financial Management

Account on Us LLC

As the owner of Account on Us, Janet has been ensuring clients bookkeeping and accounting needs are managed effectively and accurately for over 20 years.  Janet's team works hard for their clients providing exceptional reliability, flexibility, and honesty.  They will be helping QRx stay on top of its financials, handle day-to-day receivables and payables, and evolve our financial management practices as the business grows.

PAUL WISNEWSKI

Sr. Quality Consultant

Paul has been a technical leader in Quality and R&D for over 30 years.  His career includes roles in research, development, reliability, quality, and risk management for companies including Smith + Nephew Orthopaedics, Sofamor Danek and Medtronic.  Paul also has extensive people leadership experience, having managed technical teams as large as 40 or more technical professionals.  Paul holds a BS in Mechanical Engineering and MS in Bioengineering, both from Clemson University, as well as a Master of Engineering Management Degree from Christian Brothers University.  He is member of AAMI and is an ASQ Certified Reliability Engineer (CRE). 

CONTACT US

+1-833-QRX-PART (833-779-7278)