Supervisor, Quality Assurance (Mexico)

Cordis; Chihuahua; On-site; MXN 480,000 - 780,000; Full time

Job summary

Cordis is seeking a Quality/Regulatory Supervisor to lead the Quality Department, managing resources and ensuring adherence to procedures and regulatory standards in a medical device environment.

The role emphasizes staff supervision, training coordination, and CAPA execution with a focus on GMP audits, ISO 13485, and data systems such as JDE, InfinityQS, PLM, and DSI. Bilingual Spanish/English required.

Qualifications

• University degree or the equivalent combination of education and experience.
• + 4+ years of relevant experience in quality/regulatory roles.
• Experience supervising and directly managing personnel.
• Experience with product and quality system non-conformities.
• Experience with JDE, InfinityQS, PLM, and DSI data collection systems.
• Knowledge of GMP audits and ISO 13485 regulations.
• Proficient with Microsoft 365 and general IT skills.
• Bilingual: Spanish/English.

Responsibilities

• Ensure compliance with Quality System procedures and regulatory requirements.
• Coordinate resources and supervise personnel in the Quality Department.
• Assign tasks and set priorities based on operational needs and customer requirements.
• Participate in generating, reviewing, and updating departmental procedures.
• Lead corrective and preventive actions within the area and track completion.
• Ensure staff is trained and qualified for applicable procedures.
• Coordinate training for new personnel in the area.
• Handle administrative matters related to area and staff performance.
• Escalate quality issues, risks, and improvement opportunities to management.
• Ensure Health, Safety and Environment guidelines are followed in the area.

Skills

Quality management

People management

GMP audits

ISO 13485

JDE

InfinityQS

PLM

DSI data collection

Microsoft 365

Bilingual: Spanish/English

Education

University degree

Tools

JDE

InfinityQS

PLM

DSI data collection

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