Technician, Quality Engineering

Overview

The Quality Engineering Technician works within manufacturing, post-market surveillance, pre-market, Engineering and CAPA in order to perform quality investigations.

Responsibilities

• Conduct general research as part of the investigation process.- Input inspection results data into database tracking systems.- Maintain investigation files and databases.- Lead and facilitate investigations.- Support quality projects and initiatives.- Learn and maintain knowledge of manufacturing processes and associated documentation.- Read, comprehend and follow product and packaging specifications and manufacturing instructions and drawings.- Perform data reporting and trending.- Coordinate manufacture of test samples.- Coordinate and perform testing to support investigations.- 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.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.- Ability to remain calm and receptive in fast paced situations.

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