Senior Quality Specialist

• May 2022 - Present

Quality Assurance Manager

• Jul 2020 - Jun 2022

Process Manager

• May 2012 - Dec 2019

Interact with cross-functional internal teams, including Quality Assurance, to ensure demands are met and in compliance with applicable regulations including 21 CFR Part 1270 – Human Tissue Intended for Transplantation, and 21 CFR Part 1271 – Human Cells Tissues and Cellular and Tissue Based Products and ISO 13485. • Mentored and guided a team of approximately 80 members. • Managed processing of tissue intended for implant.• Organized and aligned all aspects of personnel and staffing for tissue lab that operates 24/7/365. • Performed root cause investigations for non-conformances and corrective actions as well as implementation of actions to prevent recurrence.• Subject matter expert for internal, external and FDA audits• Implemented “Near Miss” Safety program• Implemented validated database to transition from paper records to electronic records Show less

Supervisor

• Nov 2010 - May 2012

Supervise weekday night shift Dissectors and Processing Technicians to ensure efficient and compliant processing of cardiovascular tissues intended for implant. Handled staffing and personnel matters including hiring, performance management and disciplinary actions.

Team Leader

• Nov 2009 - Nov 2010

Assigned daily tasks for overnight shift and lead team of cardiovascular dissectors and processing technicians to ensure efficient processing of tissues intended for transplant.

Cardiovascular Dissector

• Oct 2005 - Nov 2009

Initially hired as a Dissector utilizing aseptic technique to process cardiovascular tissue for transplant according to SOPs.