Onsite Quality Systems Specialist – Compliance Audits

Medtronic plc; Pudahuel; Hybrid; CLP 13,392,000 - 22,320,000; Full time

Job summary

Medtronic Chile in Pudahuel, Santiago Metropolitana Region, invites a QA Auditor to join our global quality network. You will supervise quality programs, support regulatory inspections, and coordinate with internal teams to ensure compliance with ISO 13485, GDP and ISP Chile requirements.

This onsite role leverages your experience in audits, corrective actions, and documentation, with opportunities to influence quality across distribution, warehouse, and supply chain while collaborating with

Qualifications

• University degree in health-related field such as Pharmaceutical Chemist, Bioengineer, Biomedical Engineer, or related disciplines.
• At least two years of experience participating in internal, external audits and regulatory inspections, including preparation, follow-up and closing findings.
• Knowledge of Chile health sector regulatory requirements, particularly ISP.
• Knowledge of standards and quality frameworks such as ISO 13485, GDP, or other applicable quality management systems.
• Experience supporting quality processes in distribution, warehousing, logistics or supply chain is highly desirable.
• Advanced English (ability to interact with global teams orally and in writing).
• Job location: Pudahuel, Santiago Metropolitana Region, Chile.

Responsibilities

• Supervise the development and maintenance of quality programs, systems, processes and procedures to ensure policy compliance and service performance aligns with internal and external standards.
• Provide expertise and guidance interpreting policies, regulatory/governmental requirements, and internal regulations to ensure compliance.
• Work directly with operational entities to continuously monitor process analyses to enforce requirements and regulatory compliance.
• Lead preparation of audits and inspections, resolution of audit findings, and liaise with audit groups and inspectors throughout all stages.
• Prepare reports and documentation (e.g., corrective and preventive actions) and deliver to relevant internal and external stakeholders.
• Coordinate legal requests in support of governmental investigations or litigation.
• Ensure QA programs and policies are maintained and updated periodically.
• Foster application of uniform standards worldwide and enable sharing of best practices to support Medtronic’s mission globally.

Skills

Advanced English

Regulatory understanding

Audit coordination

Quality systems knowledge

Education

University degree in health-related field (Pharmaceutical Chemist / Bioengineer / Biomedical Engineer)

Tools

ISO 13485

GDP (Good Distribution Practices)

Job description

Medtronic Chile in Pudahuel, Santiago Metropolitana Region, invites a QA Auditor to join our global quality network. You will supervise quality programs, support regulatory inspections, and coordinate with internal teams to ensure compliance with ISO 13485, GDP and ISP Chile requirements.

This onsite role leverages your experience in audits, corrective actions, and documentation, with opportunities to influence quality across distribution, warehouse, and supply chain while collaborating with