Quality Engineer

Position Summary

Responsible for GMP, ISO, FDA compliance as applicable during project management and transition to manufacturing, assures customer specification and inspection methods are understood and in compliance throughout engineering project into production. Responsible for auditing quality system.

Primary Functions

• Interfaces with customers along with Quality Manager to understand and communicate product requirements and inspection requirements for new and customer supplied mold projects.
• Develops and executes procedures for product and equipment Process Validations (Installation Qualification – IQ, Operational Qualification – OQ, Performance Qualification – PQ) of new and customer supplied molds.
• Coordinates, develops, and writes product and custom equipment inspection and calibration plans for new and customer supplied molds.
• Help establish and implement strong quality systems, internal auditing, supplier approval, tooling PM, facility PM program, calibration, training and CAPA program.
• Evaluates product from DOE activities to prepare for and support parametric release and quality assurance.
• Performs and documents First Article/Protocol inspections for new, customer-supplied and modified molds.
• Uses SPC software to collect and evaluate process data for continual improvement.
• Conducts routine audits/evaluations/analysis of manufacturing, engineering, tooling and warehousing activities to assess compliance with FDA or other customer specific regulatory compliance.
• Continually updates knowledge of current state-of-the-art inspection/testing instrumentation and techniques and integrates into existing methods and programs.

Key Qualifications

• Associate or Bachelor Degree preferred.
• Three to five years-experience in-process/final/raw materials inspection experience in a high-volume production environment.
• Three to five years-experience in SPC, sampling/auditing/reading blue prints/dimensioning and tolerance.
• Practical and direct experience utilizing continual improvement and quality tools to include control charts, capability studies, DOE, regression analysis, histograms and fishbone charts.
• Practical and direct experience with computer hardware and software including LAN/CIM, and statistical, graphical spreadsheets and word processing software.
• Background in corrective action and root cause analysis, preventative action and continual improvement.
• Knowledge of ISO 9001 based Quality Management Systems (QMS).
• Knowledge of ISO 13485 Medical Devices.