Katie O'Kelly

Katie O'Kelly

Consultant

Ms. O’Kelly joined Biologics Consulting in April 2019 and has 8 years of experience in multiple engineering, quality, and leadership roles for medical device companies.

Prior to joining Biologics Consulting, Ms. O’Kelly was the Quality Systems Manager at Terumo Medical Corporation where she led the redesign of the change management system, managed the document control and records management team, and led the Change Review Board while overseeing the multi-site change management process in alignment with 21 CFR Part 820, ISO 13485 and other global medical device regulations.

Prior to that role, Ms. O’Kelly utilized her strong background in medical devices, quality systems and compliance to develop a quality integration process for medical device product and company acquisitions. She later used this process to lead multiple multi-million-dollar acquisitions through various stages from due diligence to integration completion.

Ms. O’Kelly also has deep technical experience supporting a variety of products with Johnson & Johnson and W.L. Gore & Associates as a Sr. Quality Engineer, New Product Development Engineer, and Manufacturing Engineer.

As a Consultant at Biologics Consulting, Ms. O’Kelly utilizes her technical and quality systems expertise to assist clients in the following areas:

• Quality system design, organization and development
• Quality system documentation review and preparation
• Due diligence support, including gap analyses of design history files and quality systems and development of quality integration strategies
• Technical support and review of bench testing, design documentation, risk analyses and device technical specifications for regulatory submissions
• Preparing and assisting in the preparation of all types of regulatory submissions for medical devices


Education

BS, Bioengineering, The Schreyer Honors College At The Pennsylvania State University, University Park, PA (2011)
BS, International Studies, The Schreyer Honors College At The Pennsylvania State University, University Park, PA (2011)