HELPING YOU FIND YOUR WAY TO QUALITY AND REGULATORY SUCCESS
WHAT WE OFFER
Experienced in Quality, Regulatory & Clinical Compliance for Medical Device, Pharmaceutical, Biologics, In Vitro Diagnostics, ISO 9001:2015, Automotive & Aerospace
QMS DEVELOPMENT & IMPROVEMENT
Value Beyond Compliance
EDUCATION & TRAINING
Know, Don't Guess
REGULATORY INTERACTION SUPPORT
Preparation, Response, and Remediation
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
Satisfying EU PRRC Requirements
CLINICAL/PERFORMANCE EVALUATION REPORTS
CER / PER Authoring & Review
SOFTWARE SOLUTION SERVICES
Selection, Design, & Validation
REGULATORY SUBMISSION SUPPORT
Authoring, Compilation, & Review
QUALITY SYSTEM ASSESSMENT & AUDITING
Finding Gaps & Opportunities
WHO WE ARE
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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.
As the owner of Quality Talent Network, Deb brings decades of recruiting experience to ensure QRx can offer the best expert resources to our clients. Deb has a passion for connecting great people with great opportunities. She has focused almost her entire career on the Quality profession, working directly with companies known for their quality focus and now as an independent recruiting expert.
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.
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.
Chief Client Officer & Principal Consultant
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 at St. Cloud State University’s M.S. in Medical Technology Quality Program. She was instrumental in the development of the curriculum for CAPA, Supplier Quality, Design Controls, and Quality System Design and Implementation courses.
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.
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.