Design Quality Engineer

Descripción

Resumen del Puesto: This role involves providing quality assurance for medical products, focusing on design controls, risk management, and regulatory compliance within a regulated industry. Puntos Destacados: 1. Support for significant quality issues and timely assessment of events 2. Partner with R&D to embed quality and manufacturability in new products 3. Ensure compliance with ISO 13485, FDA 21 CFR 820, and EU MDR Descripción y detalle de las actividades * 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\) * Collaborating with Supplier Quality and Supply Chain leadership on supplier\-related quality issues Experiencia y requisitos * A/BS Degree, or equivalent combination of education and experience in a technical discipline is required * 3\+ years of experience in Design Quality Engineering, Product Quality, or Manufacturing Quality within a regulated 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 Beneficios * Beneficios Superiores a LFT **Número de vacantes** 3 **Área** Calidad **Contrato** Permanente **Modalidad** Presencial **Turno** Diurno **Jornada** Tiempo Completo **Horario*** Monday to friday 08:00\-17:30 hrs **Estudios** Carrera con título profesional **Inglés** Hablado: Avanzado, Escrito: Avanzado **Disponibilidad p. viajar** No