Quality Engineer (Validation)

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Always be on the lookout for job scams! Learn more about identity theft Opens in new window Help information , opens a new window. Info First Job Previous Job 1,049 of 6,098 Next Job Last Job Share More Like This $128k Per Year Quality Engineer (Validation) TAE Life Sciences US, LLC

Occupation:

Validation Engineers

Location:

Irvine, CA - 92618

Job Type:

Regular, Full Time (30 Hours or More), Permanent Employment, Day Shift

Posted:

04/14/2026 Positions available: 1

Source:

CalJOBS

Web Site:

CalJOBS Onsite /

Remote:

Not Specified

Updated:

04/15/2026

Expires:

05/20/2026 Job #: 19848356 Job Requirements and Properties Help for Job Requirements and Properties. Opens a new window. Work Onsite Full Time Education Master's Degree Experience 24 Month(s) Schedule Full Time Job Type Regular Duration Permanent Employment Hours 40 Hours Per Week Shift Day Shift Job Description Help for Job Description. Opens a new window. Quality Engineer (Validation) sought by TAE Life Sciences US, LLC in

Irvine, CA Duties:

Develop validation procedures to ensure that all engineering and manufacturing processes and activities associated with medical device development are completed in accordance with the company's Quality Management System and applicable international standards. Oversee and lead Process Validation programs, Statistical Techniques, Production Controls, and Monitoring and Measuring of equipment to ensure the timely and high-quality execution of mechanical, physical, and visual inspections of all in-house manufactured components. Establish, implement, and maintain an

ISO 13485

2016 and EU MDR compliant quality management system. Develop, enhance, and deploy all processes and procedures related to product realization, such as incoming material inspections, manufacturing testing, and final device evaluations. Draft and review the Validation Master Plan, User Requirement Specification (URS), Functional Requirements Specification (FRS), Design Specification (DS), Test Plan and Test Cases, Test Summary Reports, Requirement Traceability Matrix, and Validation Summary Reports. Develop Quality Inspection Plans in alignment with Manufacturing Procedures and validated to Critical Quality Attributes. Coordinate the implementation and scheduling of validation testing with Procurement, Engineering, Manufacturing Engineering, and Receiving departments and personnel. Develop testing procedures and recommend improvements and enhancements for quality and manufacturing processes.

Requirements:

Master's degree, or equivalent, in Mechanical Engineering, Industrial Engineering, or related field plus two (2) years of Validation Engineering, Quality Engineering, or related experience including six (6) months of experience: validating the equipment and procedures used in development and production of drug products; developing, documenting, and validating inspection and test methods to support design control, in-process inspection, and final inspection activities; gathering system requirements and authoring system requirement specifications; developing validation master plans and standard operating procedures; implementing and maintaining a quality system compliant with ISO 13485 and FDA quality system regulation requirements; guiding Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities; developing and initiating standards and methods for inspection, testing, and evaluation; inspecting design and manufacturing facilities, performing root cause analyses, and recommending corrective actions; and developing testing methods and checking quality to ensure compliance. Telecommuting permissible 1 to 2 days a week.

Salary:

$128,400/year Send resume to: Marci Regan, Director, HR, TAE Life Sciences

US, LLC, 19631

Pauling, Foothill Ranch, CA 92610 or e-mail recruiting@tae.com. TAE Life Sciences US, LLC Is a Private Sector employer with 2 locations

Company Profile:

(Confidential) 50-99 employees Connect with TAE Life Sciences US, LLC Location/Work Site Information Help for Location/Work Site Information. Opens a new window. Cost of Living Calculator Help for Cost of Living Calculator. Opens a new window. Compensation and Benefits Help for Compensation and Benefits. Opens a new window. Job Type and Required Hours Help for Job Type and Required Hours. Opens a new window. Work Experience Help for Work Experience. Opens a new window. Education and Training Help for Education and Training. Opens a new window. Skills Required Help for Skills Required. Opens a new window. Occupation Information for Validation Engineers Help for Occupation Information for Validation Engineers. Opens a new window. Other Jobs and Employers Career Ladder Help for Career Ladder. Opens a new window. Personal Requirements Help for Personal Requirements. Opens a new window. Nature of the Work Help for Nature of the Work. Opens a new window. Work Values and Activities Help for Work Values and Activities. Opens a new window. Change Job Search Criteria Print Job Order Opens in new window [ Do you have a comment or concern about this job posting? ] About Sign In / Register Home Site Map Site Search Explore CalJOBS Settings Accessibility Statement Preferred Settings Page Preferences Languages Services For Individuals For Employers Labor Market Mobile App Legal Privacy Statement Terms of Use Disclaimer Equal Employment Opportunity Resources Protect Yourself Assistance CalJOBS Contact Us Statewide Sacramento, CA 94280 Copyright © 1998-2026 Geographic Solutions, Inc. All Rights Reserved. Virtual OneStop® - VOS Sapphire AI v24