Quality Assurance Intern

Quality Assurance Intern

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.

Essential Duties and 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.

Qualifications:

Required education and/or experience:

• Currently pursuing a bachelor's degree in Science or Engineering

Knowledge, Skills and Abilities:

• 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, Scripting Automation and Visualization Skills
• Strong communication and interpersonal skills.

Additional Qualifications (preferred)

Familiarity with following Regulations/Standards:

• 21 CFR 820
• ISO 13485

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.

Travel:

None

Equal Employment Opportunity:

Spectral MD, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state or local laws.