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Quality Assurance Intern
Spectral MDUnited States
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Über
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:
Ensureall 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 andassistwith employee training and training records as required for compliance. Assistwith revision of quality system-related documents and records. Assistwith developing andmaintainingtracking system for Quality Systems metrics Assistin other quality systems responsibilities requested by Quality Manager. Qualifications:
Required education and/or experience:
Currently pursuing abachelor'sdegree inScience or Engineering Knowledge, Skills and Abilities:
Experience working incrossfunctional organization. Excellent computer skills including MicrosoftOffice suite of products (Word, PowerPoint, Excel,Power BI,SharePoint,etc.,)as well as Data Analysis, Scripting Automationand Visualization Skills Strong communicationand 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.
Sprachkenntnisse
- English
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