Quality Systems Specialist (Hybrid)

About the role

Medtronic is seeking a Quality Systems Specialist to support its US internal customers remotely from Costa Rica. The role focuses on maintaining and improving the Quality Management System (QMS) in a regulated medical‑device environment, ensuring compliance with ISO 13485:2016 and FDA 21 CFR Part 820.

Key responsibilities

• Develop, maintain, and audit quality programs, processes, and procedures to meet internal and external standards.
• Lead audit and inspection preparation, manage findings, and coordinate with auditors and inspectors.
• Perform change control, CAPA, and documentation reviews, and support self‑audits and gap assessments.
• Generate corrective and preventive action reports and provide documentation to stakeholders.
• Analyze quality metrics using Excel or PowerBI, create trends, and drive continuous improvement.
• Support legal requests related to government investigations or litigation.

Required profile

• Minimum 2 years of experience with QMS in a regulated business (ISO 13485:2016).
• Bachelor’s degree in engineering or equivalent.
• Fluent English (C1‑C2) – written and spoken.
• Ability to work independently with minimal supervision.
• Experience supporting internal or external audit activities.
• US business (B1) or tourist (B2) visa with potential travel.

Required skills

• ISO 13485:2016
• FDA 21 CFR Part 820
• Change Control
• CAPA (Corrective and Preventive Actions)
• Good Documentation Practices
• DMAIC and Root‑Cause Analysis tools
• Microsoft Excel
• PowerBI for data analysis and trending
• Project Management basics