TL;DR
Quality Regulatory Intern (MedTech): Supporting quality management, FDA, and ISO compliance initiatives through audit resolution, project management, and software validation documentation. Focus on applying risk-based approaches to CAPA activities, Computer Software Validation (CSV), and supplier evaluation to ensure clinical workflow optimization.
Location: Must be based in Seattle, WA, US
Salary: $21–$23 per hour
Company
Getinge is a global medical technology company providing solutions for intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing to healthcare and life science institutions.
What you will do
- Participate in corporate internal audit resolution activities including data and record management.
- Manage supplier evaluation and remediation project tasks.
- Support CAPA processes including risk analysis, root cause investigation, and effectiveness verification.
- Execute Computer Software Validation (CSV) tasks, including procedure development and software periodic reviews.
- Assist in general internal audit documentation and reporting.
Requirements
- Must be currently pursuing an undergraduate or graduate degree in Engineering, Biomedical, or a related field.
- Must be able to work approximately 35 hours per week.
- Intermediate proficiency in Microsoft Office suite (Word, Excel, Outlook).
- Demonstrated analytical and problem-solving capabilities.
- Strong written and verbal communication skills with high attention to detail.
Nice to have
- Experience with AI tools
- Previous experience with ERP systems
Culture & Benefits
- Career development through hands-on experience in highly regulated medical environments.
- Opportunity to work with FDA (21 CFR 820) and ISO (13485:2016, 9001:2015) standards.
- Exposure to large-scale international medical technology operations.
- Collaborative environment focused on life-saving technology and clinical outcomes.
