Endurance Oguntimehin

Quality Systems Specialist @美敦力

ON, CA

Responsible for the monitoring and maintaining of the quality systems activities related to the distribution of medical devices, Natural Health Products (NHP), and Cells, Tissues and Organs (CTO) sold in Canada. • Ensure full compliance to the Good Manufacturing Practices (GMP) for NHP regulations, CTO, Canadian Medical Devices Regulations (CMDR) as set out by Health Canada, Medtronic World Quality and Medtronic Corporate Policies. • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.• Prepares reports and/or necessary documentation (ex. Corrective and Preventative Actions (CAPA) and provides to applicable stakeholders, both internal and external.• Co-ordinates the legal requests in support of government investigations or litigations.• Ensures the quality assurance programs and policies are maintained and modified regularly.• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company\'s mission globally.

University of Ibadan

Master's Degree, Geographical Information Systems (GIS)

Lagos State University

Bachelor's Degree, Biochemistry

University of Ibadan

Master's Degree, Environmental Chemistry and Pollution Control (ECPC)

Toronto Institute of Pharmaceutical Technology

PG. Dip., Pharmaceutical Quality Assurance / Quality Control