Alltrista - Engineer, Quality

Jadex•Greer, SC

About The Position

Responsible for GMP, ISO, and FDA compliance as applicable during project management and transition to manufacturing. Ensures that customer specifications and inspection methods are understood and followed throughout engineering projects and into production. Also responsible for auditing the quality system. The role works with customers and the Quality Manager to understand and communicate product and inspection requirements for new and customer-supplied mold projects. It develops and executes process-validation procedures for products and equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). The position also coordinates and prepares inspection and calibration plans for products and custom equipment. The Engineer, Quality helps establish and implement quality systems and programs, evaluates product from Design of Experiments (DOE) activities to support parametric release and quality assurance, and performs and documents First Article and protocol inspections. The role uses statistical process control (SPC) software to evaluate process data and conducts routine audits of manufacturing, engineering, tooling, and warehousing activities. It also keeps current with inspection and testing instrumentation and techniques and incorporates them into existing methods and programs.

Requirements

Associate or bachelor's degree preferred.
Three to five years of in-process, final, or raw-materials inspection experience in a high-volume production environment.
Three to five years of experience with SPC, sampling, auditing, blueprint reading, dimensioning, and tolerancing.
Practical, direct experience using continual-improvement and quality tools, including control charts, capability studies, DOE, regression analysis, histograms, and fishbone charts.
Practical, direct experience with computer hardware and software, including LAN/CIM, statistical and graphical spreadsheets, and word-processing software.
Background in corrective action, root-cause analysis, preventive action, and continual improvement.
Knowledge of ISO 9001-based Quality Management Systems (QMS).
Knowledge of ISO 13485 medical-device standards.

Nice To Haves

Associate or bachelor's degree preferred.

Responsibilities

Work with customers and the Quality Manager to understand and communicate product and inspection requirements for new and customer-supplied mold projects.
Develop and execute product and equipment process-validation procedures, including IQ, OQ, and PQ, for new and customer-supplied molds.
Coordinate, develop, and write product and custom-equipment inspection and calibration plans for new and customer-supplied molds.
Help establish and implement quality systems and programs, including internal auditing, supplier approval, tooling preventive maintenance, facility preventive maintenance, calibration, training, and CAPA.
Evaluate product from DOE activities to prepare for and support parametric release and quality assurance.
Perform and document First Article and protocol inspections for new, customer-supplied, and modified molds.
Use SPC software to collect and evaluate process data for continual improvement.
Conduct routine audits, evaluations, and analyses of manufacturing, engineering, tooling, and warehousing activities to assess compliance with FDA and other customer-specific requirements.
Keep current with inspection and testing instrumentation and techniques and integrate them into existing methods and programs.
Audit the quality system.