Quality Engineer

Company: US Tech Solutions
Location: San Clemente
Posted on: August 7, 2022

Job Description:

Job Title: Quality Engineer ILocation: San Clemente, CA 92673 (Hybrid)Duration: 06/07/2022 to 12/31/2022
Job Description:
The Quality Engineer will support the ICU Design Quality Engineering Department and report to the Quality Engineering Manager. The Quality Engineer is responsible for supporting Design validations and verification through adherence to design control and good documentation practice requirements.
Essential Duties & Responsibilities? Functional area tasks and responsibilities? Gather and initiate main documents of DHF: Design Input, Design Output, Design V&V and Design changesSupport and/or lead Risk Assessment (Risk Management Plan/Report, HA, UFMEA, DFMEA and PFMEA)? Support R&D in collecting data of Remediation project? Initiating testing protocols/reports ? Create and edit Design documents supporting technical Assessment, testing reports and Regulatory submission? Build productive relationships internally and externally? Work with R&D, Quality Engineers and Manufacturing Engineers on qualification of new or modified Design and Process? Support initiatives for continuous quality improvements
Knowledge, Skills & Qualifications? Knowledge of the Medical Device Industry and familiarity with ISO and FDA QSR Regulations? Proven knowledge in initiating/leading Risk Assessment (Risk Management Plan/Report, HA, UFMEA, DFMEA and PFMEA)? Proven knowledge in structuring DHF? Preferred knowledge in DOE, Process Capability, Gage R&R, etc.? Preferred knowledge in supporting Software development ? High Technical writing competency
Education and Experience ? Bachelors degree in Engineering or Technology? 3-4 years' experience in the Medical Device or Engineering Industry

Keywords: US Tech Solutions, San Clemente , Quality Engineer, Engineering , San Clemente, California