Position : Change Control Specialist

Location : Tempe, AZ

Duration : 12 Months contract

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Admin/Clerical

Level Of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Job Description

Summary of Position with General Responsibilities:

• This position is responsible for the creation and processing of all change request packets, creation of controlled documents, tracking of packets, and all associated paperwork involved.
• This requires participation as an active team member in cross-functional teams and ownership of project team documentation.
• Responsibilities also include the origination, editing, and revision of technical documentation.

• Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures.
• Assist department in cross-training team members on existing processes.

Essential Job Functions:

• Origination, editing and revision of technical documentation.
• Creation of change request and associated paperwork utilizing the Electronic Document Management System (EDMS).
• Participates in product launch documentation
• Assists Project Managers in monitoring the progress of the assigned project and makes adjustments as necessary to ensure the successful completion of the project
• Complete ownership of team documentation for New Product Development (NPD), or product transfers, including creation and launch of change requests (CR).
• Applies skills and develops documentation including operating procedures, process flow charts, and manufacturing procedures.
• Perform clerical duties as necessary, i.e. typing, filing, maintenance of databases, and preparation of general correspondence.
• Uses various computer software applications to complete assigned work activities.

• This is not intended to be an all-inclusive listing of duties. Other job-related duties may be required.

Basic Qualifications:

• Excellent oral and written communication skills in English are required.
• Previous experience in the medical device industry preferred.
• Proven experience in working in a cross-functional team environment as well as the ability to function independently.
• Ability to define and create solutions to challenges or opportunities
• Ability to communicate with all levels of technical and operations personnel
• Ability to complete position responsibilities with limited direct supervision
• Works on straightforward tasks using established procedures; work is subject to review by others.
• Good attention to detail is a must.
• Ability to work in a team environment and to communicate clearly and effectively.
• Ability to multi-task and prioritize workload. Positive and professional attitude.