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 *****, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC *******)- 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 *****- 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 traceabilityBeneficios- Beneficios Superiores a LFT**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario**- Monday to Friday 08:*****:30 hrs**Estudios** Carrera con título competente**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p.viajar** Si

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