Peter Vander Aa Email & Phone Number

Lake Geneva, Wisconsin, Us

ISO 13485:2016 Standard as well as ISO 13485:2016 Auditor/Lead Auditor training.• On the job experience with root cause analysis and corrective action.• Completion of CAPA's, SCAR's, and NCR investigation.• Perform daily a.m. presentation to executive management team (Quality, Operations, Engineering, Sales, Human Resources, IT, Production and senior leadership) reviewing 24-hour department metrics pertaining to safety, quality, productivity, delivery and cost.• Daily use of ERP system in generating process flow/scheduling for department guidance.• Produce highly-precise, multi-faceted medical device components/implants with approx. 25% of all features on drawing tighter than .001" total tolerance (down to .0001" total).• Discretionary authority and ability to choose/modify tools for most efficient operation of processes.• Perform continuous in-process inspection using mechanical/automated inspection techniques - comparators, vision systems, microscopes, carbide plug/ring gages, carbide threaded plug/ring gages, bore gages, concentricity gages, micrometers, indicating micrometers, intertest gages, mold-making, etc.• Work closely with Quality department to adjust machine settings/tooling as necessary.•Knowledge and daily use of Fanuc controls (21i, 31i and 32i). •Setup/operate deep-hole drilling operations (.0005” max concentricity on 3/16” bore across 6” length).•Perform 100% visual inspection under magnification (6x – 10x) inspecting for burrs/frills, chatter, surface finish, discoloration, general anomalies, etc.