Supervisor, Quality Assurance (Mexico)

Cordis; Ciudad Juárez; On-site; MXN 360,000 - 480,000; Full time

Job summary

Cordis busca un gerente de Calidad/Regulación en Mex‑Juárez para liderar el sistema de Calidad y seguridad. Supervisará personal y recursos, coordinará procesos y garantizará cumplimiento de GMP e ISO 13485.

Se requiere experiencia en auditorías, dominio de JDE/InfinityQS/PLM y habilidades de comunicación efectivas en español e inglés. Puesto de tiempo completo, ubicado en Juárez, con enfoque en cumplimiento y mejora continua.

Qualifications

• Título universitario o combinación equivalente de educación y experiencia.
• Mínimo 4 años de experiencia relevante y experiencia en supervisión.
• Conocimiento de GMP y auditorías ISO 13485.
• Conocimientos de sistemas: JDE, InfinityQS y PLM.

Responsibilities

• Gestionar recursos humanos, materiales y equipos del área de Calidad.
• Coordinar actividades y garantizar cumplimiento de procedimientos y normativas.
• Participar en acciones correctivas y preventivas y seguimiento de su cierre.
• Formar y evaluar al personal del área y asegurar su competencia.
• Comunicar riesgos, recursos y mejoras al nivel directivo.

Skills

Liderazgo

Gestión de calidad

Bilingüe: Español/Inglés

Comunicación

Education

Título universitario o cifra equivalente

Tools

JDE

InfinityQS

PLM

DSI data collection

ISO 13485 knowledge

Job description

Las Visión de Conjunto

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life‑saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

At Cordis, we're teammates, not just employees. We embrace an empowered and one‑team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

We are the people behind the people who keep saving lives.

Responsabilidades

Manages the human, material, and equipment resources assigned to the Quality Department; coordinates and supervises the activities of the personnel under their supervision; and verifies compliance with applicable procedures, practices, regulatory requirements, and quality standards. Ensures the effective execution of Quality and Safety Management System activities, contributing to the achievement of departmental, operational, and company objectives.

Key Responsibilities

• Maintains and ensures compliance with the applicable procedures and requirements of the Quality System within its area of responsibility.
• Coordinates the human resources, materials and equipment assigned to their area to ensure the execution of departmental activities.
• Coordinates the assignment of tasks of the personnel under their charge and establishes work priorities according to the operational needs and the requirements of internal and external customers.
• Participates in the generation, review, and updating of departmental procedures, ensuring their correct implementation.
• Participates in and follows up on corrective and preventive actions related to their area, ensuring that the assigned activities are executed within the established times.
• Ensure that the personnel under their charge are properly trained and qualified in the procedures and activities applicable to their functions.
• Coordinates and follows up on the training of new personnel assigned to their area.
• Attends to administrative matters related to the area and the personnel under their charge, including follow‑up on attendance, training, performance and operational needs.
• Communicates to the next level of management the quality issues, risks, resource needs, and opportunities for improvement identified within their area.
• Ensures that the personnel under their supervision comply with the company's guidelines related to Health, Safety and Environment, and verifies that the necessary resources to carry out their activities are available and in adequate condition.
• Complies with and ensures compliance, within its area of responsibility, with the company's procedures and policies, as well as applicable local, state, and federal laws and regulations.
• It complies with the Quality procedures and regulatory requirements applicable to the markets where the company's products are marketed.
• Performs other tasks assigned according to the needs of the area and the organization.

Calificaciones

Required Qualifications

• University degree or the equivalent combination of education and experience required. Requires a total minimum of 4+ years of relevant experience.
• Experience in supervision and direct personnel management.
• Experience with product and quality system non‑conformities.
• Experience with the JDE system.
• Experience with the InfinityQS system.
• Experience with the PLM system.
• Experience with the DSI data collection system for product release.
• Knowledge of and experience with GMP audits.
• Knowledge of the ISO 13485 standard and regulations applicable to medical device manufacturing.
• Knowledge of computers and Microsoft 365.
• Bilingual: Spanish/English.

Preferred Qualifications

• Experience working in regulated cleanroom manufacturing environments.

General Provisions

The company reserves the right to add, remove, or modify assigned duties at any time. To successfully perform this job, an individual must be able to carry out each essential function satisfactorily. The minimum qualifications listed are representative of the

Ubicaciones de empleo

MX‑Juarez

Categoría

Quality/Regulatory

Tipo

Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact