Quality Control Device Engineer

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Quality Control Device Quality Engineer (QCD QE) provides support with equipment troubleshooting, investigation and root cause analysis, new equipment qualification and validation, analyst training and equipment improvement projects.   Essential Job Functions:   Assists in identifying root causes and coordinates corrective action for quality/testing issues in the QCD Lab (supporting investigation write up/approvals as required). Evaluates equipment or process problems and designs testing to determine possible causes or solutions. May also be called on to harmonize measurement techniques between the site and supplier. Assists QCD Lab management with technical issues involving injector functionality, component testing, and protocol execution. Compiles quality data, which includes: gage R&R 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. Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance. Designs and executes FAT/SAT and Equipment Qualification and Validation on new equipment, and ensures compliance of existing equipment. Designs and executes Quality Engineering related protocols, and summarizes studies to ensure consistency of data production and compliance with manufacturer, MMT and current Good Manufacturing Practices. Capable of singular project management (within the realm of Quality Engineering) for smaller scope Quality Engineering projects. Ensures product development activities have all necessary Quality Engineering supporting justifications for test methods and equipment being developed. May interact with third party customers, outside testing laboratories and provides Quality Engineering assistance where needed on specific issues.      Basic Qualifications:   Bachelor’s Degree in an Engineering related field 3 years pharmaceutical, laboratory, manufacturing or quality engineering related experience Thorough knowledge of cGMPs related to device testing and Quality Validation. Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc. Possesses a working knowledge of statistical methodology as it relates to laboratory testing.  Ability to understand and apply mathematical concepts towards Quality Engineering tasks, especially as it relates to statistics and probability. Ability to apply mathematical operations to such tasks as frequency distribution, determination of tests, analysis, sampling, and process capabilities. Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective Action/Preventative Action (CAPA) for recommendation to management. Ability to write reports, business correspondence, and procedure manuals. Proficient in Microsoft Office (Word, Excel, Access, PowerPoint), Project Management Software (such as Microsoft Project, SmartSheets, etc.), Statistical Software (such as MiniTab, StatGraphics, PH Stat, etc.) and Data Acquisition Software (such as ASI, Datamyte). Familiar with various measurement gages used in Quality Control labs, knowledge of various types of mechanical testing.   Preferred Qualifications:   Medical Device Industry experience Knowledgeable with FDA Design Control Regulations and Guidance for Devices or Combination Products (21 CFR Part 4, 21 CFR Part 820) and medical devices. Experience with medical device plastic molding, manufacture/processing of plastic injection molding, glass molding for cartridges, rubber compounding and molding, metal stamping operations, labels and packaging, printed material manufacture and control, measurement equipment and calibration techniques.   #LI-On-Site