Quality Engineer II
Artech Information Systems LLC
Quality Engineer IISupports manufacturing quality engineering activities for new and existing medical device products. Focus on process implementation, validation, defect investigation, and compliance documentation in a regulated manufacturing environment.Top Required SkillsMedical Device Quality & Regulatory Knowledge1–3+ years experience in medical device industryFamiliar with FDA 21 CFR Part 820, EU MDR 2017/745Knowledge of ISO 13485, ISO 14971, IEC 60601Proficient in MS Office (Word, Excel, PowerPoint, Access), Windows OSRoot Cause Analysis / InvestigationsFailure analysisCorrective and Preventive Actions (CAPA)Data-driven problem solvingProcess & Equipment ValidationProcess validation / equipment validationSoftware or spreadsheet validationValidation documentation and execution
Vacancy posted 2 days ago
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