Production Quality Engineer (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Production Quality Engineer (Medtech): Managing quality production activities and monitoring KPIs for home sleep apnea test devices with an accent on failure investigation, process validation, and NPI integration. Focus on root cause analysis, CAPA management, and optimizing production yield through data-driven reporting.
Location: Onsite in Caesarea, Israel
Company
Medical device technology company focusing on diagnostic tools for respiratory sleep disorders, specifically the WatchPAT family of portable home sleep apnea tests.
What you will do
- Monitor and report production quality KPIs, focusing on first pass yield and failure trends.
- Perform failure investigations and Root Cause Analysis (RCA) in collaboration with engineering.
- Plan, write, and execute validations for production processes and tools.
- Manage NCR, CAPA, SCAR, and MRB processes to ensure operational effectiveness.
- Support R&D and Engineering in integrating new processes during NPI (New Product Introduction).
- Analyze quality data and prepare weekly and monthly reporting presentations.
Requirements
- Bachelor's degree in Electronic, Mechanical, or Industrial Engineering.
- 3+ years of experience in multidisciplinary medical or pharma assembly/production line support.
- Proven experience in production line problem-solving.
- Strong knowledge of mechanical assemblies and PCBA manufacturing requirements.
- Fluent English (reading and writing documents).
- Expert level Hebrew (Preferred).
Nice to have
- Experience working with ERP and PLM systems.
- Knowledge of Medical Regulatory standards.
Culture & Benefits
- Mission-driven environment focused on improving patient outcomes and saving lives.
- Culture that values innovation, self-motivation, and an entrepreneurial spirit.
- Opportunity to grow within a global company operating in over 140 countries.
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