WHO WE ARE
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Chief Executive Officer &
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.
Chief Operating Officer &
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.
Chief Client Officer &
Jackie has over 30 years experience and deep expertise in quality, regulatory, pre-clinical and clinical compliance. She has served in Senior Global roles for companies including Beckman Coulter, NAMSA, CIMA Labs, PDL BioPharma, Arizant/3M, and Heraeus, 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 an adjunct faculty member in St. Cloud State University’s M.S. in Medical Technology Quality program.
& Account Management
Bringing over a decade of experience, Christina has been employed in quality assurance, medical device regulatory affairs, and business development. She gets involved in supporting 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 provide solutions to problems and mapping the best path toward future success in their businesses. Christina has a Bachelors of Science in Chemistry from the University of Minnesota, with an emphasis in analytical and organic chemistry.
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.
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.
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.
Chief Financial Officer
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.