Kaan Kozluca

• Quality Management Responsible Cliniclands A.B. (Sweden) • Teamlead of Quality Specialists • Auditing of supplier according to MDR, ISO 13485, ISO 9001 and GDP • Implementation and rollout of the SOP computerized system validation according to ISO 13485, MDR and GDP • Oversee the corporate brands complaint handling process in Europe • Coordination of Recalls and Warehouse Alerts in central EU • Review and negotiation of Quality assurance agreements • focal contact point in EU to conduct rework activities

• Teamlead of Quality Specialists • Implementation of supplier monitoring according to MDR GDP and ISO 13485 • Oversee the corporate brands complaint handling process in Europe • Creation of Audit program and Auditing of supplier • Establish & implement KPI tracker for EU Quality System • Implementation and rollout of internal Audit SOP • Implemenation and rollout of CAPA and DoC Check SOPs • Review and negotiation of Quality assurance agreements • focal contact point in EU to conduct rework activities

• Teamlead of Quality Specialists • Control and Management of crucial supplier according to ISO 13485:2016 and MDR requirements. • Planning and implementation of external audits at OEM/Supplier • Deploy EU audit program • Implementation of Auditor qualification program EU • Identification of non-conformities, definition of measures and follow-up of corrective actions. • Introduction of a risk-based approach and audit strategy for OEM in Europe

• Leading supplier quality improvement projects • Leading the Incoming Goods Inspection Team (Incoming Ispection and Complaint Handling) • Oversee Approved Supplier List, Supplier Quality agreements/questionnaires, • Depoly yearly Audit program • Conduct supplier audits and follow up of findings • Implement Supplier Quality SOPs on site • Conducting internal audits and supporting external audits (TÜV, FDA, etc.). • Creating incoming goods inspection plans in the CAQ system (Babtec)

• Implementation of in-process controls • Creation and approval of first-piece article test reports • Development of test instructions and incoming goods inspection protocols • Participation in the design change process • Restructuring of the incoming goods area • Implementation and rollout of CAQ software (Babtec)

Maschinenbau

Zusatzqualifikation als „Staatlich geprüfter Wirtschaftsassistent“