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Jason Gromek

Partner, Senior Business Development Director, CBA, CQA at MEDIcept Inc.

Jason Gromek is an experienced professional in the medical device industry with over 20 years of experience in design, quality systems, quality engineering, and regulatory compliance.12 He currently serves as the Executive Vice President of Sales and Operations at MEDIcept Inc., where he leads the Sales, Quality, Regulatory, and Clinical teams.1

Before joining MEDIcept, Jason was the Founder and President of BioDevice Design, LLC, a medical device development company.12 BioDevice Design was a founding member organization of America Makes – National Additive Manufacturing Innovation Institute, which was established to promote 3D printing in manufacturing.1

Throughout his career, Jason has held various management roles in both consulting and industry positions. He has been responsible for implementing and ensuring compliance with 21 CFR 820 and ISO 13485 Quality Management Systems, as well as overseeing Product Development Lifecycle activities and U.S. and EU regulatory guidance.1

Some of Jason's other notable experiences include:

  1. Director of Engineering and Development at Meditech Spine12
  2. Medical device design consultant for O'Savage Biomechanics12

Jason holds multiple patents in the area of spinal implants and led the initiative to obtain regulatory clearance for Hydroxyapatite PEEK while at Meditech Spine.1 He is a member of ASQ (American Society for Quality) and holds certifications as a Certified Biomedical Auditor and Certified Quality Auditor.1

Jason Gromek received his education from The University of Akron and Lakeland Community College.2

Highlights

Dec 2 · medicept.com
Our Team - MEDIcept
Our Team - MEDIcept
Jun 28 · bbrpartners.com
Stephanie J. Gromek - BBR Partners
Mar 27 · theorg.com
Jason Gromek - Sales And Operations at MEDIcept Inc. - The Org
Jason Gromek - Sales And Operations at MEDIcept Inc. - The Org
Press Release—MEDIcept Partnership - Arena Solutions

Related Questions

What are some of Jason Gromek's most notable achievements at BioDevice Design?
How did Jason Gromek contribute to the America Makes – National Additive Manufacturing Innovation Institute?
What regulatory challenges did Jason Gromek overcome at Meditech Spine?
Can you provide more details about the patents Jason Gromek holds in spinal implants?
What is Jason Gromek's role at MEDIcept and how does it differ from his previous positions?
Jason Gromek
Jason Gromek, photo 1
Jason Gromek, photo 2
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Location

Cleveland, Ohio, United States