Quality Engineering Technician- Post Market

Posting Date 2 months ago(10/10/2022 3:20 PM)
Requisition ID
2022-11721
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc - Bloomington
Category
Quality

Overview

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.

Responsibilities

• 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

Qualifications

• 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

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed