Quality Engineer

Koch•Costa Mesa, CA

16d•Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

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

Responsibilities

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