Quality Engineering Technician- Post Market

Posting Date 2 months ago(10/10/2022 3:20 PM)
Requisition ID
Job Location(s)
Bloomington IN United States
Less than 10%
Position Type
Full Time
Cook Inc - Bloomington


The Quality Engineering Technician at Cook Incorporated works within Post Market Quality Engineering in order to perform complaint investigations and to support post market activities.


• Review incoming complaints, identifying additional information required from customers, customer relations, and/or field representatives
• Follow-up with customer relations and/or field representatives, as needed
• Perform reviews of Device Master Record, including device drawings, specifications, manufacturing instructions, quality control instructions, etc.; identify and escalate gaps related to complaint failure modes
• Perform reviews of Device History Records; identify and escalate potential nonconforming product distributed to the field
• Perform visual, dimensional, and/or functional analysis of complaint devices in biohazard lab using appropriate measurement equipment
• Perform additional testing, as needed, to support investigations
• Document investigation activities, conclusions, and conclusion codes within complaint handling software system
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
• Support quality projects and initiatives
• Communicate findings to internal and external customers


• High school diploma or GED
• Associates degree preferred
• Working knowledge of investigation methods and tools
• Knowledge of medical device regulations, including pertinent standards and guidance preferred
• Strong organizational skills
• Critical thinking and attention to detail required
• Excellent verbal communication skills and technical writing
• Proficient in Microsoft Word/Excel/Outlook


Physical Requirements:

• General office environment, including time in manufacturing environment and biohazard lab
• Utilizes close visual acuity for working with computers and equipment
• Frequently required to sit, stand, walk, and communicate


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