Quality Systems Lead: Medical Devices Compliance

Medtronic; Buenos Aires; On-site; ARS 1,200,000 - 1,800,000; Full time

Job summary

Medtronic seeks a Quality Systems Specialist to oversee quality programs and regulatory compliance at its Buenos Aires facility. You will manage audits, inspections, and documentation to ensure adherence to internal and external healthcare standards.

Join our team to apply expertise in ANMAT regulations and ISO 13485, while supporting global collaboration and continuous improvement across R&D and operations.

Qualifications

• University degree in pharmaceutical chemistry, bioengineering, or biomedical engineering.
• Minimum two years experience in internal, external, and regulatory audits.
• Professional experience in medical device companies.
• Knowledge of Argentine health sector regulations (ANMAT).
• Familiarity with ISO 13485, GDP, or other applicable quality management systems.
• Advanced English proficiency for global team interaction.
• Distribution, warehouse, logistics, or supply chain quality process experience preferred.

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

Skills

Quality systems

Audits

Regulatory compliance

English proficiency

Education

University degree

Tools

ISO 13485

Job description

Medtronic seeks a Quality Systems Specialist to oversee quality programs and regulatory compliance at its Buenos Aires facility. You will manage audits, inspections, and documentation to ensure adherence to internal and external healthcare standards.

Join our team to apply expertise in ANMAT regulations and ISO 13485, while supporting global collaboration and continuous improvement across R&D and operations.