דרושים»תוכנה» Senior Quality Assurance (QA) Engineer

לפני 1 שעות Engineer")Location: Job Type: Key Responsibilities:

QMS & Audits: Lead QMS improvements and manage the Internal Audit program. Design Assurance: QA representative for NPD; review/approve DHF, V&V, and Deputs/Outputs. Risk Management: Lead ISO 14971 activities, including dFMEA and pFMEA. Change Control: Evaluate product/process changes and perform regulatory assessments (FDA/MDR). CAPA & Complaints: Lead root cause investigations for NCs, CAPAs, and customer complaints (Vigilance/MDR). Validation: Oversee IQ/OQ/PQ for manufacturing, software, and microbiology.Requirements: Requirements: B.Sc. in Engineering or Life Sciences. 5-8 years of QA experience in the Medical Device industry (Class II). Expertise in ISO 13485:2016, EU MDR, and FDA 21 CFR Part 820. Strong leadership in ISO 14971 (Risk Management). Experience with DHF, Change Control, and V&V frameworks. Certified Internal Auditor - an advantage. (Proven skills in Root Cause Analysis (CAPA/NC) *This position is open to all candidates. Hide