Quality and Regulatory Director with experience in manufacturing of sterile implantable devices, disposable medical devices, medical diagnostics products (IVD), orthopedic implants and instruments and research and development of bio-pharmaceuticals. Special expertise in developing and maintaining a quality system, regulatory compliance, customer complaint handling, and company Standard Operating Procedures with expertise in FDA regulated facilities. Excellent communication and leadership skills with the ability to motivate a diverse group. Area of experience includes: Specialties: Internal and external audits • FDA audit experience • CAPA and failure investigation reporting • Supplier Quality Assurance • Sterilization and process validations • cGMP, QSR and ISO 13485 • Certified Lead Auditor • Customer complaint Handling

Director of Regulatory Affairs and Quality Assurance @ Quality/Regulatory Director Senior department head responsible for regulatory updates, design control, process and product validation activities, CAPA, Complaint Management and all other regulatory and quality activities. From January 2013 to Present (3 years) Houston, Texas AreaDirector of Ra/QA @ From January 2013 to Present (3 years) Quality Assurance Manager @ From March 2008 to February 2013 (5 years) Quality Engineer @ From 2006 to 2008 (2 years) Quality Assurance Engineer @ From 2006 to 2008 (2 years) Parent @ From 2001 to 2007 (6 years)

BS, Biology @ Howard University From 1984 to 1988 Bioligical Sciences @ Westbury high school From 1980 to 1983 Jacqueline Jean-Baptiste is skilled in: ISO 13485, FDA, Process Validation, Quality Systems, Medical Devices, Certified Lead Auditor, Project Management, Manufacturing, Quality System, V&V, Sop, Quality Assurance, GMP, Regulatory Affairs, CAPA