Quality Systems Lead – ISO 13485 & Regulatory

Medtronic; Lo Barnechea; Presencial; CLP 12.000.000 - 18.000.000; Jornada completa

Descripción de la vacante

Medtronic Chile is seeking a Quality Auditor to oversee the development and maintenance of quality programs, ensuring compliance with regulatory standards and internal guidelines. The role involves coordinating audits, interpreting health regulations, and collaborating with operations to sustain high-quality processes.

The ideal candidate has a university degree in a health-related field, at least two years of audit experience, and advanced English for global collaboration.

Formación

• University degree in a health-related field (e.g., Pharmacist, Biomedical Engineer)
• At least two years of experience participating in internal audits, external audits, and regulatory inspections
• Knowledge of health sector regulatory requirements in Chile, particularly ISP
• Knowledge of quality standards and frameworks such as ISO 13485, GDP, or other applicable quality management systems
• Experience supporting quality processes in distribution, warehousing, logistics or supply chain environments is highly desirable
• Advanced English (ability to interact with global teams orally and in writing)

Responsabilidades

• Oversee the development and maintenance of quality programs, systems, processes and procedures to ensure policy compliance and service performance aligns with internal and external guidelines
• Provide expertise and guidance interpreting regulations and internal policies to guarantee compliance
• Collaborate with operational units to continuously monitor process analyses and ensure regulatory adherence

Conocimientos

Advanced English

Educación

University degree in health-related field (e.g., Pharmacist, Biomedical Engineer)

Herramientas

ISO 13485

GDP

Descripción del empleo

Medtronic Chile is seeking a Quality Auditor to oversee the development and maintenance of quality programs, ensuring compliance with regulatory standards and internal guidelines. The role involves coordinating audits, interpreting health regulations, and collaborating with operations to sustain high-quality processes.

The ideal candidate has a university degree in a health-related field, at least two years of audit experience, and advanced English for global collaboration.