Quality Systems Specialist/ Chile

Medtronic seeks a Quality Systems Specialist in Santiago, Chile to oversee quality assurance programs, regulatory compliance, and audit management within medical device distribution and supply chain operations. The role involves supervising quality processes, interpreting regulations, and ensuring adherence to internal and external standards.

Responsibilities

• Oversee development and maintenance of quality programs, systems, processes, and procedures ensuring regulatory compliance
• Provide expertise on interpreting regulatory policies, governmental regulations, and internal rules for compliance
• Monitor process analyses continuously with operational entities to enforce requirements and maintain regulatory standards
• Lead audit and inspection preparation, resolve audit findings, and liaise with auditors throughout inspection stages
• Prepare reports and documentation including corrective and preventive actions for internal and external stakeholders

Requirements

• University degree in health-related field such as pharmaceutical chemistry, pharmacy, biochemistry, or biomedical engineering
• Minimum two years experience in internal audits, external audits, and regulatory inspections including preparation and closure
• Knowledge of Chilean health sector regulatory requirements, particularly those from Instituto de Salud Pública
• Familiarity with quality standards and frameworks including ISO 13485 and Good Distribution Practices
• Advanced English proficiency for oral and written communication with global teams
• Experience supporting quality processes in distribution, warehouse, logistics, or supply chain environments preferred