Kaan Kozluca

• Quality Management Representative for Cliniclands AB (Sweden) and BA International Ltd. (UK) • Overall responsibility for Supplier Quality Management in EMEA • Management of a Europe-wide team of Quality Specialists • Strategic oversight and execution of external, internal, and supplier audits • Leadership of projects aimed at harmonizing quality management processes across EMEA • Implementation and rollout of CAQ software (CAQ AG Document and Training module)

• Quality Management Lead for Cliniclands A.B. (Sweden) • Lead Quality Specialists Team • Supplier onboarding, monitoring & audits (MDR, GDP, ISO 13485) • Implementation of computerized system validation SOPs • Oversee EU-wide complaint management & recall coordination • EU wide KPI tracking • Rollout of training & awareness programs across Europe • Negotiate & review Quality Assurance Agreements • Key contact for rework activities across the EU

• Lead Quality Specialist Team • Oversee EU-wide complaint management & risk assessment • Supplier onboarding, monitoring & audits (MDR, GDP, ISO 13485 & ISO 9001) • Oversee KPI tracking & quality strategy across Europe • SOP rollout & process optimization (Audits, CAPA & DoC Checks) • Drive training & awareness programs for EU sites • Negotiate & review Quality Assurance Agreements • Key contact for rework activities across the EU

• 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) • Coordinate improvement projects such as projects, complaint investigations, CAPA, raw material trends • Oversee Approved Supplier List and Supplier Quality agreements • Conduct supplier audits and follow up of findings • 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“