Quality Assurance Intern at Spectral MD Inc

Dallas, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Sep, 26

Salary

0.0

Posted On

03 Jun, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Design History File, Device Master Record, Engineering Change Order, Equipment Calibration, Data Analysis, Scripting Automation, Visualization Skills, Microsoft Office, Power BI, SharePoint, Interpersonal Communication

Industry

Biotechnology Research

Description

Position Summary: 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.

Responsibilities

The intern supports Engineering and Quality Assurance teams by performing quality activities for medical imaging device development and manufacturing. Key tasks include maintaining the Design History File, managing equipment calibration, and updating quality system records.