Quality Engineer

Koch•Costa Mesa, CA

17d•Onsite

About The Position

Our Costa Mesa, CA facility is seeking a Quality Engineer to support manufacturing of injection molded parts and assembly. 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 an Engineering Field or 5 + years of direct Quality experience
At least 1+ years Quality/Regulatory experience
Legally authorized to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship

Nice To Haves

Auditing experience preferred
Knowledge of injection molding
Experience working with an ERP system (SAP)

Responsibilities

Use quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques
Assist the development of essential QMS deliverables/Advanced Product Quality Planning (APQI) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation
Monitor production processes and products for adherence to company and regulatory standards and practices
Participate in quality improvement initiatives and projects
Perform quality reviews and internal audits; evaluate data and write reports to validate or indicate deviations from existing standards
Review and approve change requests
Manage the qualification of processes performed by suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
Facilitate communication between engineering, manufacturing, and quality functions
Responsible for being a communication liaison between the customer and manufacturing facility