Quality Engineering Technician - (Temporary 6 month contract)

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

Permanent