Quality Engineer I

Job description

Job DetailsJob Location: Xeridiem - Tucson - Tucson, AZ 85714Position Type: Full TimeJob Shift: 1st ShiftJob Purpose: Support and maintain compliance of the medical device Quality Management System (QMS) by performing quality engineering activities under guidance. Ensure all medical devices are manufactured in accordance with FDA regulations, ISO 13485:2016, and internal quality and safety standards. Essential Duties and Responsibilities: Ensure compliance with FDA 21 CFR Part 820, ISO 13485:2016, and other applicable regulatory and quality standards for medical device manufacturing. Support and maintain quality system processes including CAPA, Nonconformance (NC), Complaint Handling, Document Control, Risk Management, and Supplier Quality. Act as a key user of the Electronic Quality Management System (iQMS), ensuring accurate data entry, reporting, and system maintenance for quality-related activities. Understand and assist with incoming, in-process, and final product inspections, including sampling plans, inspection methods, and measurement system analysis to support production. Participate in internal audits and assist in external (regulatory, notified body, customer, and suppli...