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Quality Engineer
2 months ago
- Experience Required: 3-5 years
- Preferred Industry: Medical devices, but other manufacturing fields are acceptable
- Nonconforming Material Control: Manage MRB (Material Review Board) process for nonconforming materials from suppliers.
- Supplier Investigations: Support investigations related to nonconformances with suppliers and identify corrective actions.
- Supplier Monitoring: Assist with supplier scorecards, audit management, and continuous improvement projects.
- Cross-Functional Collaboration: Work with cross-functional teams on material disposition and corrective actions.
- Nonconformance Management: Oversee nonconforming materials, follow up on corrective actions, and work with the Material Review Board.
- Supplier Quality Activities: Monitor suppliers, help with scorecards, and implement quality improvements to reduce costs and improve yields.
- Documentation and Analysis: Analyze defects using tools like Pareto analysis, export data to Excel, and handle basic quality analysis.
- Quality Tools: Experience with CAPA, Material Review Board processes, and quality hold processes.
- Manufacturing Environment: Experience in a manufacturing setting; familiarity with various parts (PCBs, pumps, metal, molded parts) is a bonus.
- Standards Knowledge: Familiarity with ISO 13485, FDA, GMP, or ISO 9001.
- Engineering Background: Ability to read and interpret technical drawings/specs; understanding of part failures.
- ERP Systems: Experience with Oracle or SAP preferred.
- Computer Skills: Proficiency in Office Suite, especially in data analysis and Excel.
- Preferred Degrees: Mechanical, Biomedical, or Industrial Engineering.
- Alternative: Engineering background with relevant quality experience.
