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Partner, Finance and Partnerships
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.
Partner, Operations and Resourcing
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.
Business Development & Partnerships
Michel grew up in Sweden and came to the US for college where he got a Bachelor of Science degree in Finance from St. Cloud State University. He is a sales and business development executive with over 30 years of experience working for SMEs in the technology, medtech, and industrial product and services markets. He has been a contractor at QRx Partners since 2022, focusing on new business development with start-ups and early state medtech companies.
Account Management
Bringing over a decade of experience, Christina has been employed in quality assurance, medical device regulatory affairs, and business development. She supports all sizes of medical device companies, such as Boston Scientific and Medtronic, to small start-ups. She has a passion for partnering with clients to solve problems and mapping the best path toward future success in their businesses. Christina has a Bachelor of Science in Chemistry from the University of Minnesota, with an emphasis in analytical and organic chemistry.
Recruiting Management
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.
Consultants
Natasha Overbo
​Natasha has been a leader in Quality Management for over 20 years. Her career includes roles in Quality Leadership, Quality Systems development and implementation, e-QMS/Computer System implementation and validation, Notified Body Lead Auditor, Regulatory Affairs and Design Assurance/Product Software V&V, including Medtronic, St. Jude Medical, Cantel Medical, Philips (Medical Systems Netherlands), WuXi AppTec and Endogenex. Natasha has also been an Adjunct Visiting Professor at the Instituto Tecnologico de Costa Rica for the last 9 years. She holds a B.S. in Information Technology (Capella University) and Computer Programming (St Paul College) , and certifications in multiple quality systems management standards, auditing, and IT systems.
Mark J. Swanson
​Mark started his professional career in quality more than 25 years ago in an ISO 9000 manufacturing environment and has spent the past the past 15 years in medical device, primarily in quality systems as an engineer and auditor for Boston Scientific, St. Jude, Abbott, and Philips. Mark currently holds audit certifications as a Medical Device Auditor (CMDA), ISO 9001 Auditor, ISO 17025 Lead Assessor, and ASQ Six Sigma Green Belt, in addition to FDA MDSAP and EU MDR/IVDR.
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Barb Ferrante
Barbara’s professional career in quality spans 30 years, with 18 years in medical device quality. Her career includes roles in Quality Leadership, Quality Systems development and implementation, e-QMS implementation and validation, CAPA systems and as a Certified Biomedical Auditor, including Allergan, St. Jude Medical and several medical device startup companies.
Nancy J Teasdale
Nancy is an accomplished Regulatory Affairs Professional with over 30 years of experience in the pharmaceutical and biotechnology industry. She has a understanding of the complex regulatory landscape governing drug development, clinical trials, manufacturing controls, and product approvals. She is skilled in working with the FDA’s Center for Drug Evaluation and Research (CDER) and Office of Orphan Drugs (OOD) within the Oncology, Neruology, Urology and Dermatology Divisisons.
Connor Griggs
​Connor has been a leader in Regulatory Affairs for over 10 years, beginning his career with the FDA supporting 510(k) and PMA reviews. He specializes in medical device regulatory strategy, quality systems development, post-market compliance, and project leadership, with extensive experience leading FDA and EU MDR submissions, global supply chain initiatives, and supplier transfer projects resulting in multimillion-dollar cost savings. Connor holds a Master of Science in Regulatory Affairs and Services and is an ISO 13485:2016 Lead Auditor with multiple certifications in FDA QSR, EU MDR, and global quality systems.