Senior Quality Engineer Qualifications: • Medical Device Experience with knowledge of 21CFR820 preferred. • Investigational research skills • Experience with any statistical software packages (Minitab a plus) • Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS preferred. • Knowledge and working application of reading and understanding blueprints and technical drawings. • Knowledge of process improvement methodologies such as Lean Six Sigma. • Strong communication skills with the ability to engage in complex technical and project management issues, both verbally and in writing. • Ability to manage multiple projects simultaneously, prioritize effectively and meet tight deadlines. • Demonstrated strong analytical problem solving (Root Cause Investigations) • Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools). • Computer competency in Word, Excel, Power Point, Minitab, Access and databases. • Ability to multi-task and methodically manage projects.