Mark Harper

Compliance Manager, Quality Assurance & Regulatory at Bridge to Life Ltd.

Mark Harper has over 30 years of experience in the Quality Assurance and Regulatory Affairs space. Mark began their career in 1991 as Quality Control Manager at Sampson Coatings. In 1996, they moved to Natural Biologics, Inc. - Solutions by nature, where they were Quality Assurance Manager and Quality Control Manager. From 2002 to 2005, they worked at Pemstar as FDA Compliance Manager and Program Manager. Mark then joined GE Healthcare in 2005 and held various roles, including Senior Auditor (QMS), Global Quality Assurance Director - QMS, QARA Sr. Site Leader, and Global Quality Systems Programs Manager. From 2016 to 2018, Mark was at Bradshaw- A company of In'Tech Medical, where they served as Director of Quality Assurance and Regulatory Affairs and Senior Regulatory Affairs Manager. During this time, they were responsible for analyzing observations, leading internal investigations to assess all affected processes, and creating a comprehensive Corrective and Preventative Action (CAPA) plan. Mark then moved to Spectrum Plastics Group in 2018, where they held the roles of Director Quality Systems and Director Global Quality. Currently, Mark is the Director Quality Assurance Regulatory Affairs at Bridge to Life Ltd.

Mark Harper attended Cardinal Stritch University from 2008 to 2010, where they earned a degree in Management Information Systems (MIS). Prior to that, they attended Virginia Commonwealth University from 1986 to 1991, studying Business Administration. Mark also obtained an ASQ-CQA certification from ASQ in February 1997.

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