Quality Engineer

Your Job

Our Costa Mesa, CA facility is seeking a Quality Engineer to support the manufacturing of injection molded parts and assembly operations.

We are seeking a quality professional who can provide strong technical leadership, drive root cause investigations, and support continuous improvement initiatives in a regulated manufacturing environment.

Our Team

Phillips Medisize, a Molex Company, is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries.

What You Will Do



* Use quality tools to implement improvements, including process flowcharting, Pareto analysis, correlation and regression analysis, significance testing, design of experiments (DOE), statistical process control (SPC), gauge R&R, and trend analysis


* Lead and facilitate root cause investigations and corrective action activities


* Assist in the development of Quality Management System (QMS) deliverables and APQP activities, including complaint analysis, risk analysis, FMEA, CAPA, and process/equipment/software verification and validation


* Monitor production processes and products for adherence to company and regulatory standards


* Participate in and lead quality improvement initiatives and projects


* Perform quality reviews and internal audits; evaluate data and prepare technical reports


* Review and approve change requests


* Manage supplier quality activities, including process qualification, corrective actions, and supplier performance improvement


* Facilitate communication between engineering, manufacturing, and quality functions


* Serve as a liaison between customers and the manufacturing facility on quality-related matters

Who You Are (Basic Qualifications)



* Bachelor's degree in Engineering OR 4+ years of Quality Engineering experience


* Experience working in a manufacturing environment


* Experience leading root cause investigations and problem-solving initiatives


* Legally authorized to work permanently in the United States for any employer without requiring visa sponsorship or transfer

What Will Put You Ahead



* 10+ years of engineering and/or quality engineering experience


* Experience managing FDA inspections, audits, and regulatory interactions


* Strong technical writing experience


* Experience interfacing directly with customers


* Experience reading and interpreting technical drawings


* Knowledge of injection molding processes


* Experience with ERP systems (SAP preferred)


* Experience in regulated medical device manufacturing environments

For this role, we anticipate paying $80,000- $110,000 per year.

This role is eligible for variable pay, issued as a monetary bonus or in another form.

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