Production and supplier Quality Engineer
On-site · Petaẖ Tiqva, Central District, Israel
Job Summary
Production and Supplier Quality Engineer role in a regulated medical device environment focused on ensuring product quality, patient safety, and field reliability across the Installed Base. Responsibilities include supporting qualifications and control of ATE testers in V&V and production lines, ECO/ECR processes and NPI projects, supplier audits, cross-functional quality improvements with R&D/manufacturing, driving Six Sigma/Lean and RCA initiatives, supporting RMA/DOA processes, and maintaining compliance with ISO 13485, FDA 21 CFR 820, MDR, and related risk management documentation (CAPA, NCRs). Requires a Bachelor’s in Engineering and 3+ years of quality experience; strong problem-solving skills and knowledge of QA tools and production/testing, with emphasis on medical device regulations and risk management. Fluent in English.
Required Qualifications
- Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related)
- 3+ years of experience in Quality; medical device experience strongly preferred
- Familiarity with ISO 13485, FDA 21 CFR 820, ISO 14971 risk management
- Strong analytical and problem-solving skills; RCA tools experience (5-Why, Fishbone, etc.)
- Excellent communication and collaboration skills
- Fluent in English
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