Descripción y detalle de las actividades
- Provide escalation support for significant quality issues
- Ensure timely assessment and containment of quality event
- Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material
- Own and oversee quality input to post-release design and process changes (ECOs, deviations, waivers, temporary changes)
- Ensure thorough change impact assessments are performed to determine verification, validation, revalidation, and documentation requirements
- Ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented
- 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)
- Collaborating with Supplier Quality and Supply Chain leadership on supplier-related quality issues
- Ensure supplier changes impacting released products are properly evaluated and approved
- Support strategy for incoming inspection,



supplier controls, and quality agreements
- Act as a key quality leader partnering with Manufacturing Engineering, Design Engineering, Operations, Regulatory Affairs, Clinical, and Supply Chain
- Lead, mentor, and develop a team of Sustaining Quality Engineers
- Set clear priorities, goals, and performance expectations aligned with business and quality objectives
- Ensure appropriate staffing, training, and skill development to support production needs.

Experiência y requisitos
- Bachelor's degree or equivalent combination of education and experience in a technical discipline is required.
- English (Fluent)
- 5+ years of experience as a Quality Manager in the medical, aerospace, or automotive sector.
- 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

📌 Manager, Sustaining Quality Assurance Engineering (Mexicali)
🏢 Masimo
📍 Mexicali