Quality Intern

Job Description

This position supports the Quality Management Dept. with a variety of projects and processes, including: process analysis and development, document control, technical writing, and work instruction development. This role will develop the applicant’s skills in FDA/TUV compliance within a medical device manufacturing environment.

To perform this job successfully, an individual must be able to perform the following satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

• Responsible for all aspects of developing and implementing a Quality Visual Management System including:
• Document review & updates
• Training procedures and oversight
• Change control for documents and processes
• Corrective action workflow and administration
• KPI reporting
• Work on site in Arlington Texas 40 hours/week
• Other duties may be assigned

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

· Currently enrolled in a college or university bachelor’s degree or master’s degree program in a related field (Industrial, Manufacturing, Mechanical, Biomedical Engineering)

· Excellent organizational and time management skills

· Exhibits sound and accurate judgement

· Knowledge of process analysis

· Strong interpersonal skills and motivational skills

· Ability to adapt to changes in the work environment with short notice

· Thrives in a fast-paced team environment

· Basic computer skills (including Word, Excel, Outlook, PowerPoint)

Preferred:

· Understanding of Quality Systems, Procedures, & Regulations (FDA and ISO medical device manufacturing)

· Lean Manufacturing/Six Sigma Training (Yellow Belt)

· Software skills: Visio, MS Project, Minitab

Additional Information

Physical requirements:

· Must be able to use a keyboard, computer mouse and computer monitor for 8 hours at a time

· Must be able to sit at a desk for approximately 8 hours per day while using a computer and phone

Language skills:

Ability to read and interpret training documents, safety rules, operating manuals, maintenance instructions and procedural documents in English.

Mathematical skills:

Ability to calculate figures and measurements. Ability to quickly perform simple calculations while performing tasks related to specific work parts.

Reasoning ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to apply reason to problems such as determining the correct sequence of actions to take when repairing a work piece.

Required reporting:

This position is responsible for reporting of the following metrics on a regular basis:

· As instructed by the Department Manager

· Other reports and information as required

Work environment:

· Work is performed in an office environment and/or a manufacturing environment

· The employee may occasionally be exposed to dust

· The employee must be able to work in a fast-paced, team environment

· The employee must be able to adapt to frequent changes and rapid company growth