Medical Device QMS Internship

Overview:Learn how to implement and maintain a Quality Management System for medical device development and manufacturing, aligned with ISO 13485:2016 and FDA QSR.

Learning Outcomes:

• Write SOPs, Work Instructions, and Process Flows.

• Perform internal audits and gap assessments.

• Create design control documents: DMR, DHF, DHR.

• Monitor non-conformances and CAPA workflows.

Tools & Technologies:

• Google Workspace, Confluence, Jira, MasterControl (if available)

• ISO 13485:2016, FDA CFR Part 820

Real-Time Projects:

• ISO 13485 documentation and version control

• Internal audit checklists

• Training logs and traceability matrix

Ideal For:Life science, regulatory, quality, or healthcare engineering students aspiring for QA/QMS roles in medtech.