Responsibilities Provide escalation support for significant quality issues Ensure timely assessment and containment of quality event Partner with R&D; to embed quality and manufacturability into new product designs Support design controls for development and sustaining changes Participate in design reviews with a strong focus on producibility and risk Ensure design changes are manufacturable, verifiable, and compliant Support verification & validation activities with production-representative builds Support risk management (DFMEA, use-related risk, production risk inputs) Investigate design-related production issues and quality escapes Translate production floor feedback into actionable R&D; design improvements Ensure design documentation and traceability (DHF, requirements, V&V;) are audit-ready Support audits and inspections related to design controls Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material Ensure sustained compliance with applicable regulations and standards, including ISO *****, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC *******)



Collaborate with Supplier Quality and Supply Chain leadership on supplier-related quality issues Qualifications A/BS Degree, or equivalent combination of education and experience in a technical discipline is required 3+ years of experience in Design Assurance Quality Engineering, Product Quality, or Manufacturing Quality in medical device industry Must have working knowledge of quality systems and practices Must be able to provide guidance to functional teams on quality requirements Experience in Quality Systems per ISO ***** Ability to work in a Project Team Environment Direct experience supporting manufacturing of regulated medical products Strong working knowledge of CAPA, nonconformance management, change control, and root cause analysis Excellent verbal and written communication skills Excellent prioritizing, organizational, and interpersonal skills Excellent documentation skills including detail-oriented, record maintenance/tracking and understanding of document traceability #J-*****-Ljbffr

📌 Design Assurance Quality Engineer (Mexicali)
🏢 Masimo
📍 Mexicali