Quality Systems Specialist/ Chile

Medtronic · Santiago, Chile

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QualityFull-timeCompany career page

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What they're looking for

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

What you'll be doing

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

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