Senior Quality Engineer

NAMSA•Irvine, CA

20d•$68,800 - $133,700

About The Position

The Senior Quality Engineer manages measurement and test equipment (M&TE) procurement, qualification, requalification, validation, maintenance, and documentation for laboratory and engineering systems. The role ensures equipment and electronic data processes meet applicable requirements and standards, supports laboratory personnel and client audits, and drives equipment reliability and process improvements. The position also supports building expansion validations, engineering software systems, and engineering drawings.

Requirements

Bachelor's degree in engineering or a related scientific discipline.
5 to 7 years of related work experience.
Experience with Microsoft Word and Excel.
Knowledge of regulatory requirements, requirement specifications, system qualifications and protocols, equipment operating procedures, standard operating procedures, and validation reports.
Strong written and verbal communication skills.
Strong organizational and time-management skills.
Ability to work effectively both as part of a team and independently.

Responsibilities

Manage equipment procurement and help identify or develop criteria for procuring and installing laboratory M&TE in accordance with testing standards.
Design and execute equipment qualifications, requalifications, and process validations under applicable biotechnology and pharmaceutical regulations and standards.
Analyze raw data from qualifications, requalifications, and validations and prepare final reports.
Work with IT to ensure equipment generating electronic data complies with 21 CFR Part 11.
Investigate and troubleshoot issues using advanced mathematical and engineering knowledge.
Complete nonconformance, corrective action, and preventive action documentation.
Prepare, review, and maintain M&TE technical documents, including protocols, reports, SOPs, and EOPs.
Review raw data for qualifications, calibrations, and equipment service.
Write and implement change control plans and risk assessments.
Coordinate and document scheduled and unscheduled equipment maintenance.
Requalify, validate, and troubleshoot sterilizers and resistometers.
Drive purchasing processes for materials and services needed by departments owned or supported by the role.
Maintain equipment documentation in the Equipment Management System.
Train laboratory and support staff on equipment use, and train associates on new and existing equipment and processes.
Drive trending and analysis of test equipment failures.
Install, qualify, and maintain Siemens monitoring points.
Assist laboratory personnel with continuous monitoring and alarm investigations.
Administer and perform maintenance and upgrades of engineering software systems.
Create and maintain associate user accounts for engineering systems.
Write and execute building expansion validations.
Update and maintain engineering drawings for buildings, equipment, and systems.
Provide equipment records to staff for client audits and act as a qualification and validation subject matter expert where appropriate.
Apply standard engineering techniques to improve processes and help laboratories identify equipment needs for proactive planning.
Ensure electronic and paper equipment files are appropriately retired or archived.