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Ofek AraziOA
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Ofek Arazi

@ofekarazi

Quality Specialist with focus on medical-device QMS, inspections, documentation, and nonconformance investigations, board leader, AI improvements

Israel
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What I'm looking for

I'm looking to contribute to any environment where I can improve quality systems, investigations, documentation, inspections, and cross-functional operational processes. I love AI, medical devices, technology, and people!

At Baxter, I managed the full nonconforming-material lifecycle for Starling Monitor, from identification and root-cause analysis through disposition and closure. I hosted bi-weekly MRB meetings reviewing more than 100 NCRs annually and ensured records met ISO 13485, Baxter procedure, and KPI requirements.

I've also led AI-assisted workflows for DHR reviews, NCR/CAPA investigations, and quality-procedure development. My work includes incoming inspection, change control, ESD guidance and equipment testing, and preventive maintenance of measuring and test equipment.

At Sight Diagnostics, I assembled and tested OLO Hematology Blood Analyzer devices, performed mid-production DHR reviews, and trained new employees on assembly and testing. I also improved production documentation through change control.

Earlier, I assembled Smart 532 photocoagulator laser heads at Lumenis and designed, assembled, tested, and quality-checked fine optical and mechanical systems in an IDF special technology unit. I bring careful ownership, continuous improvement, and kind, professional teamwork to regulated manufacturing environments.

Experience

Work history, roles, and key accomplishments

Education

Degrees, certifications, and relevant coursework

Udemy logoUD

Udemy

Professional Certificate, Quality Assurance

Completed courses on IQ OQ PQ and ISO13485, and MDR 2017/745.

Tech stack

Software and tools used professionally

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