Ilker Kilic
Design Quality Engineer Iii at Artivion Emea
Based in Hechingen, Germany
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Seniority
Staff
Department
Engineering
Location
Hechingen
Industry
Medical Equipment Manufacturing
Company size
225
Contact information
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i•••••••@artivion.com
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Background
About Ilker Kilic
Most audit findings are not about missing documents.They are about missing evidence chains.I am a Design Quality Engineer working with Class medical devices, with 7+ years of experience in regulated MedTech environments across Germany and Turkey.I help MedTech teams turn scattered quality documents into defensible, audit-ready evidence chains.My work focuses on validation, ISO 14971 risk management, CAPA, EU MDR, ISO 13485, FDA QSR / 21 CFR 820, design controls, traceability and audit-ready documentation.I write about the practical side of MedTech Quality- DHF and design control gaps- CAPA logic- validation evidence- audit readiness- traceability mistakes- quality systems that look complete but fail under questioningFree MedTech QA toolkits are available in the Featured section of my profile.Reviewing a CAPA, audit, or MDR file and stuck on where the evidence breaks? Feel free to DM me.
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- LWManager
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