About this role
Senior Staff Design Quality Engineer at CooperCompanies. Location: La Garita, Alajuela, Costa Rica. Role: leading design, managing suppliers, conducting investigations Requirements: 10+ years quality engineering in medical devices (8+ with MS). Advanced knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR, ISO 14971; experience with design controls, V&V, risk management, CAPA, and supplier quality. Category: Quality Assurance Seniority: Senior Level Tools: Microsoft Excel, Microsoft Word, Microsoft PowerPoint, FMEA, PPAP Certifications: asq quality engineer, lean, six sigma, dfss, project management Commitment: Full Time Workplace: Hybrid Languages: English