Quality Assurance Engineering Technician, Location: Tempe, AZ, Salary Range: $19/hr, Position: Quality Engineer

Description: Responsible for partnering with the Quality Engineer to support numerous Quality Assurance tasks and initiatives. Customer Complaint Investigations and conducting investigations for CAPA projects and Non-conformances. Requires thorough understanding of Root Cause Analysis and strong focus in maintaining adequate documentation of activities. Collects, analyzes, and presents manufacturing data to Quality Engineering. Executes procedural updates as required by Quality Engineering. Proposes solutions to a variety of technical and operational issues regarding quality concerns and/or necessary process improvements. Executes research and test protocols as assigned by Quality Engineering. Authors investigational procedures as deemed necessary by Quality Engineering.

Supports execution of Validation studies. Reads and interprets drawings, specifications and protocols. Applies appropriate statistical methods to solve technical or operational issues. Applies knowledge of reprocessing technologies to existing manufacturing processes, potential process improvements, product quality issues/concerns and/or any additional areas as deemed necessary by Quality Engineering. Maintains appropriate documentation for all activities. Develops technical understanding of device design and clinical functionality. Mentors and coaches less experienced Quality Engineering Technicians, Production Associates, and QIAs in regards to Quality functions such as inspection methods, acceptance criteria, field non-conformances, and any additional areas as deemed appropriate by Quality Engineering. Conducts Customer Complaint investigations. Conducts Nonconformance investigations. Performs duties associated to Customer Complaint device login and maintains integrity of Complaint Device room. Supports CAPA activities as required by Quality Engineering. Performs Calibration of critical test or process equipment. Performs other duties as assigned by Quality Engineering and/or Quality Assurance Management. This position is a100% lab based position working with medical devices that may be contaminant. PPE is provided. Check in devices by taking pictures of the devices and uploading into the database. Responsible for helping with very basic investigations that are repetitive. Examples include investigating broken bed brackets, broken power adapters and batteries that are not functioning. Minimal electrical testing will be performed. Work will be highly repetitive.

Requirements: Associate degree in technical discipline or equivalent demonstrated experience with focus on Root Cause Analysis. Previous medical device industry experience required; must demonstrate basic knowledge of QSR requirements and inspection and/or test technology and methods. Demonstrated technical aptitude. Good troubleshooting and problem-solving skills. Strong knowledge and previous application of Excel, Word, PowerPoint, and Visio. Familiar with the application of standard quality tools, including SPC, process mapping, and root cause analysis. Strong written and oral communication skills. Must function effectively in a dynamic work environment. Must be a strong, independent problem solver with excellent verbal and written communication skills. 1 Minimum year of experience required, Experience in QC, QA, Production environments with high quotas of output with high quality expectations. Must be good with computers as all investigations required an investigation write up. Strong experience with data entry, Microsoft word and excel, Skilled at navigating and toggling between computer programs.

Please contact: tom@oncoreusa.net