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 13485, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC 60601-1)




- 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 13485
- 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

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