About the position
The Quality Assurance Intern supports the cross-functional Engineering and the Quality Assurance team by performing various quality activities related to design, development, testing and manufacturing of a medical imaging device while continuously maintaining and improving of the Spectral MD's Quality System in compliance with applicable regulations and standards.
Responsibilities
- Ensure all project documents are filed and updated regularly in the Design History File for each project.
- Maintain Device Master Record and organize engineering drawings.
- Track Engineering Change Order action items, closeout, and filing.
- Manage equipment calibration and inventory.
- Monitor and assist with employee training and training records as required for compliance.
- Assist with revision of quality system-related documents and records.
- Assist with developing and maintaining tracking system for Quality Systems metrics.
- Assist in other quality systems responsibilities requested by Quality Manager.
Requirements
- Currently pursuing a bachelor's degree in Science or Engineering.
- Experience working in cross functional organization.
- Excellent computer skills including Microsoft Office suite of products (Word, PowerPoint, Excel, Power BI, SharePoint, etc.) as well as Data Analysis and Visualization Skills.
- Strong communication and interpersonal skills.
Nice-to-haves
- Familiarity with following Regulations/Standards: 21 CFR 820, ISO 13485.
