Tom Riniker

Experience

• 

  Grant Thornton

  Feb 1994 - Feb 1997

  Senior Consultant

  Provided business process improvement, quality, and regulatory consulting services to the Medical Device, Automotive, and general manufacturing industries.

• 

  St. Paul Consulting, LLC

  Feb 1997 - Dec 2017

  Founder

  As the Founder/Principal of St. Paul Consulting, Tom was responsible for sales, operations, finance, and project management for this management consulting firm offering quality and regulatory consulting services to the medical device, pharmaceutical, automotive, and general manufacturing industries. During his time in this role, Tom:• Individually sold and delivered consulting products and services to medical device manufacturers in the U.S., Europe, South America, and Asia.• Led the implementation of quality management systems at numerous companies and achievement of registration to ISO 9001, ISO 13485, QS-9000, and TS 16949.• Led remediation efforts at multiple medical device manufacturers to successfully resolve FDA 483s, Warning Letters, and Consent Decrees. Show less

• 

  GN Otometrics

  Jul 2011 - Jun 2017

  As General Manager of the company's Canadian Operations, Tom was responsible for both the Sound Room Division and the Equipment Sales and Service Division of this Class II medical device manufacturer. His responsibility included all aspects of the following business activities: product development, sales and marketing, quality, regulatory, operations, finance, and manufacturing. During his time in this role, Tom:• Led the redesign of the company's flagship sound room products • Planned and implemented the launch of sound room products to the U.S. and European markets • Oversaw the 300% growth of sound room sales revenues during his time in the position• Planned and carried out the move of all sound room production to a new facility• Redesigned sound room manufacturing layout and processes to triple production capacity• Grew equipment sales/service revenues an average of 15% in each of 3 years Show less As the Director of Global Regulatory Affairs and Quality Assurance, Tom was responsible for leading an international RA/QA Team that coordinated regulatory and quality assurance activities at numerous sites of this Class II medical device manufacturer. During his time in this role, Tom:• Implemented one global, automated QMS to serve EU, U.S., South America, and China; resulting in greater efficiency, improved compliance, and reduced headcount.• Reengineered the company’s new product development process, improving consistency, compliance, design robustness, and speed to market.• Created a Customer Care Group that collected all feedback from the market, evaluated it, and created prioritized project recommendations for R&D. Show less

  • General Manager

    Jul 2014 - Jun 2017

  • Director of Regulatory Affairs/Quality Assurance

    Jul 2011 - Jul 2014
• 

  Stillwater MedTech Consulting

  Jan 2018 - now

  Chief Executive Officer

  As Co-Founder and CEO of Stillwater MedTech Consulting, Tom is responsible for sales, operations, and delivery of consulting services for this Minnesota-based management consulting firm.