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!
Ofek Arazi
@ofekarazi
Quality Specialist with focus on medical-device QMS, inspections, documentation, and nonconformance investigations, board leader, AI improvements
What I'm looking for
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
Managed nonconformance material lifecycle as MRB Lead, hosted bi-weekly meetings, and ensured compliance with ISO13485. Led AI-assisted workflow implementations and performed incoming inspections and ESD officer duties.
Education
Degrees, certifications, and relevant coursework
Udemy
Professional Certificate, Quality Assurance
Completed courses on IQ OQ PQ and ISO13485, and MDR 2017/745.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Salary expectations
Social media
Job categories
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