Quality Engineer II
Artech
Quality Engineer II
Supports 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 Skills
Medical Device Quality & Regulatory Knowledge
- 1–3+ years experience in medical device industry
- Familiar with FDA 21 CFR Part 820, EU MDR 2017/745
- Knowledge of ISO 13485, ISO 14971, IEC 60601
- Proficient in MS Office (Word, Excel, PowerPoint, Access), Windows OS
Root Cause Analysis / Investigations
- Failure analysis
- Corrective and Preventive Actions (CAPA)
- Data-driven problem solving
Process & Equipment Validation
- Process validation / equipment validation
- Software or spreadsheet validation
- Validation documentation and execution
Vacancy posted 1 day ago
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