Christine (Chris) Park is a seasoned Quality Assurance professional with a wealth of experience in establishing and remediating quality systems of all sizes. Using a pragmatic approach to compliance and quality assurance, Ms. Park has successfully focused on results-oriented solutions that integrate quality into the daily business activities of organizations. Her experience in R&D and general manufacturing for medical devices, IVDs, and biotech/pharmaceuticals provides a well-balanced background for her work in compliance.

Whether working on a full quality system or on key quality components (CAPA, complaints, audits, supplier quality, management controls), Ms. Park provides employees and management not only with adequate direction and tools to maintain compliance, but also with the understanding of why they must comply with specific requirements.

Ms. Park has played an active role in the generation and review of technical documentation in support of regulatory submissions. Her direct experience includes facilitating product and process risk assessments, change management (design as well as manufacturing), product and process validation plans and protocols. She has developed strong relationships with manufacturing as well as design/development organizations.