Quality Engineer 2 Job in Saint Louis, Missouri US

Quality Engineer 2

Job ID :963038 Responsibilities : The essential duties of this position include but are not limited to: - Designs, executes Quality Engineering related protocols; and summarizes studies to ensure consistency of data production and compliance with manufacturer and King Pharmaceutical's specifications with current Good Manufacturing Practices. - Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters. - Capable of singular project management (within the realm of Quality Engineering) management/direction for smaller scope Quality Engineering Plans. - Issues data, memos, presentations and reports concerning Quality Engineering projects or areas of interest. - Evaluates equipment or process problems (internal and at suppliers as needed) and designs testing to determine possible causes or solutions; assists in determining process capability of new equipment. May also be called on to harmonize measurement techniques between King site and supplier. - Assists in ensuring product development activities have all necessary Quality Engineering supporting justifications. Including Product Requirement Docs/ Testing Requirement Docs, Tolerance Stack Review, Product and Process FMEAs and MPIDs. - Interacts with third party customers, outside testing laboratories and Suppliers to provide Quality Engineering assistance where needed on specific issues. Including investigational and statistical support. - Assists in identifying root causes and coordinate corrective action to quality issues in Packaging and Inspection and the Sterile Facility. - Quarantine product or components as necessary in the course of investigation. - Assist SQC lab supervisor with technical issues involving injector functionality, component testing, and protocol execution. - Assists in compiling quality data, which includes: gage RR studies, process capability studies, trending of product defects, trending of functionality data for finished product, dimensions on components or finished product, raw material inspection/sampling, incoming component inspection. - Training inspectors, SQC technicians, and supervisors on the following: new procedures, new equipment, new measurement methods, new inspection criteria, Component/product defects and failure modes. Qualifications : BS in an Engineering related field, with four to six years pharmaceutical, laboratory, manufacturing or Quality Engineering related experience. Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired but not mandatory.