Quality and Compliance Manager (Tijuana)

Descripción

Company: METTLER TOLEDO
Location: Parque Sur Industrial, Col. El Realito
Industry: Precision Instrument Manufacturing

Scope: Ensure product quality and compliance are maintained up to regulations, internal and customer requirements.

Resumen

Supports manufacturing on assembly, testing, validation, introduction, evaluation, validation, regulatory standard management, change management and process design for manufacturability. Manages the quality engineering team supervising and mentoring quality assurance staff, providing training, and ensuring adherence to best practices.

Responsabilidades Principales

• Supports manufacturing transfer and NPI projects, ensuring quality and regulatory compliance.
• Ensures product quality through manufacturing quality control and KPI management.
• Supervises document control function and document distribution.
• Manages Quality Manual, SOPs and related WI and standard procedures, by ensuring they are followed, updated, trained on, and aligned to regulatory requirements.
• Is in charge of supervising the entire quality team, including the Backoffice and shop floor personnel, thus providing support and guidance to ensure duties are performed effectively.
• Manages internal audits schedule and ensures the involved team covers it.
• Ensures manufacturing validations and test method validations are performed as per customer and regulatory requirements.
• Collaborates on the development of production line layouts and assembly line fixturing drawings.
• Manages certification and surveillance audits for FM/ATEX/IECEX, UL, NTEP and CE.
• Helps develop test methods, defines test equipment, ensures calibration is up to date and documented in the system.
• Manages quality system and ensures KPIs for QNs, CAPAs and Complaints are up to standard and processed in a timely and effective manner.
• Oversees supplier quality control.
• Communicates and coordinates with global quality team to ensure alignment for the Tijuana plant.

Experiencia y requisitos

Skillset: Analytical thinking, attention to detail, regulatory knowledge, manufacturing knowledge for medical or electronic products, leadership, good communication, creative, responsible, organized, punctual, constant, cooperative, and capable of managing.

Experience: 5+ years of experience in electronic/medical manufacturing (2+ years in supervisory or senior role preferred).

Formation: Knowledge and experience on quality systems preferable on the following ISO9001:2015, UL, FM/ATEX/IECEX, CE, OIML, CSA, health, and safety regulations.

Education: Industrial engineering or similar career.

Fluent English: spoken and written.

Beneficios

Beneficios de acuerdo a la LFT.

Información adicional

Número de vacantes: 1
Área: Calidad
Contrato: Permanente
Modalidad: Presencial
Turno: Diurno
Jornada: Jornada completa
Horario: Tiempo completo
Estudios: Carrera con título profesional
Inglés: Hablado: Avanzado, Escrito: Avanzado
Disponibilidad p. viajar: Si