A creative, adaptable, and relational Mechanical Engineer with 12+ years of cross-functional experience in the quality, regulatory, and design aspects of medical device development and 5 years of experience managing a team.Extensive experience building and optimizing QMSs for a variety of companies and devices. Direct experience with US Class III (PMA) implant devices, Class 1 reusable surgical instruments, FDA inspections, notified body audits, process validation, design verification and validation, clean environment manufacturing, injection molding, manual assembly, steam sterilization, gamma sterilization, sterile packaging, labeling, marketing claims reviews.- Extensive experience with 21 CFR 820 (QSR/QMSR) including design controls and ISO 13485- ISO 13485:2016 Certified Lead Auditor (CQI & IRCA)- EU MDR (2017/745) Certified Auditor (CQI & IRCA)- RAPS Regulatory Affairs Certified (RAC-Devices)