Quality Engineer Coordinator -CAPA

Posting Date 2 months ago(1/4/2018 5:24 PM)
Requisition ID
2018-3655
Job Location(s)
Bloomington IN United States
Travel
None
Shift Type
First
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

The Quality Engineer - CAPA Coordinator at Cook Inc. supports implementation and management of department processes and metrics The coordinator assists with organization, management, and reporting of QE- CAPA processes to ensure department objectives are being met.

Responsibilities

• Organize and maintain documentation and metrics critical to CAPA for the Quality function
• Gather data as needed for QA and other Cook functional areas
• Help propose and participate in the update meetings related to CAPA progress (i.e. CAPA monthly Management Review)
• Monitor and report on QE- CAPA processes as specified by management
• Compile and distribute reports regarding compliance, quality measures and business metrics
• Support CAPA planning preparation and tracking
• Prepare and Participate in CAPA Review Board Meetings

Qualifications

• Associates degree or equivalent in a technical discipline or experience of such kind and amount as to provide a comparable background
• 1-3 years of experience in an FDA regulated industry is highly preferred

• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) preferred
• Strong communication skills required
• Critical thinking and attention to detail required
• Excellent verbal communication skills and technical writing

 

Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

 

Physical Requirements:

• Works under general office environment conditions
• Sitting for extended periods
• Utilizing close visual acuity for working with computers and equipment

• Frequently required to stand, walk, use hands to grasp, carry, feel or touch, reach with hands and arm, talk, and hear

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