QA Supervisor – Medical Devices & GMP Compliance

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

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.