Quality Systems Intern

2 months ago
Requisition ID
2017-2988
Job Location(s)
Bloomington IN United States
Shift Type
First
Position Type
Internship
Company
Cook Inc.
Category
Internships

Overview

The Quality System intern position is a 12-week paid internship located in Bloomington, Indiana. It is offered for a period extending from mid-May through mid-August (exact dates depend on school calendars.) This position includes 401(k) options, access to a fitness center, onsite cafeteria option, an assigned mentor, one-time housing stipend, capstone presentation, intern events, and more. All internships provide hands-on experience with meaningful projects in the Medical Device Manufacturing Industry.

 

First round consideration will be given to individuals who apply by October 20, 2017.

 

Responsibilities

The Quality System intern will focus on assisting the Quality Systems department to ensure initiatives for Cook Inc. quality management system are compliant with global medical device regulations, standards and that guidance as such requirements are created and revised.

 

Through the internship the intern will gain the following:

  • Gain an intermediate understanding of 21 CFR and ISO 13485 requirements for the medical device industry and basic level of knowledge for outside U.S. requirements
  • Appropriately identify intelligence from various internal and external sources that may impact the Cook Inc. quality management system
  • Management cross-functional preliminary assessment and analyses tasks to support comprehensive quality system document deliverables
  • Experience effective communication with cross-functional personnel at various organizational levels to accomplish compliance related objectives

 

Specific Job Functions/ Duties

  • Gather, interpret, track, and disseminate regulatory requirement changes
  • Assess regulatory requirements to determine potential for Cook Inc. quality management system impact
  • Assist in compilation of analyses to document Cook Inc. quality management system alignment and/or identify gaps to regulatory requirements
  • Participate in development of solutions to ensure regulatory requirement alignment and track actions to closure
  • Provide support to other Quality Systems department functions, such as quality planning, commitment action tracking, external audit hosting and response process, and management review data compilation, as needed

 

Potential Projects:

  • Management review quality data analysis and visualization improvements
  • Development of SharePoint site and/or other electronic system workflows

Qualifications

• All candidates should have an interest in a career in the Life Sciences field, a willingness to take initiative, and an ability to work well with others

• Candidates should be students entering their Junior or Senior year the following fall semester or entering graduate school; candidates who graduate the spring semester before this internship are also eligible

• A minimum GPA of 3.0 is preferred

• All candidates must provide proof of enrollment (including pre-registration certification for the following fall) for consideration

• Multiple disciplines will be considered (e.g. Life Sciences, General Business, and Management) 

 

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