Medtronic seeks a Quality Systems Specialist to oversee quality programs, processes, and regulatory compliance at its Buenos Aires facility. The role involves managing audits, inspections, and documentation while ensuring adherence to internal and external healthcare standards.

Responsibilities
- Oversee development and maintenance of quality programs, systems, and procedures ensuring regulatory compliance
- Provide expertise on regulatory policies, governmental requirements, and internal regulations for compliance
- Supervise continuous process analyses with operational entities to enforce requirements and meet regulations
- Lead audit and inspection preparation, findings resolution, and liaison with auditors and inspectors
- Prepare reports and documentation including corrective and preventive actions for stakeholders

Requirements
- University degree in pharmaceutical chemistry, bioengineering, or biomedical engineering




- Minimum two years experience in internal, external, and regulatory audits with preparation and findings closure
- Professional experience in medical device companies
- Knowledge of Argentine health sector regulations, particularly ANMAT requirements
- Familiarity with ISO 13485, GDP, or other applicable quality management systems
- Advanced English proficiency for integral team interaction
- Distribution, warehouse, logistics, or supply chain quality process experience preferred

Join our Research & Development (R&D;) team and contribute to Physical AI, AIoT, IoT, AI/ML, intelligent sensing, Edge AI, connected systems, and emerging technologies through research, experiments, prototypes, and proof-of-concept development.

Research Areas
- IoT & ...

📌 Quality Systems Specialist (Buenos Aires)
🏢 Medtronic
📍 Buenos Aires