Quality Systems Engineer

Senior Quality Systems Engineer | Medical Devices On-site | Competitive Salary + Bonus This is a senior, strategic quality role with a growing medical device company. You will lead the company's Quality Management System (QMS) and make sure it meets FDA, ISO 13485, MDSAP, and EU MDR requirements. You will own CAPA, nonconformance, and product correction processes. You will also lead training and reporting for Quality Systems, working closely with cross-functional teams and supporting audits. What you will own: CAPA system maintenance, development, and validation Product and process nonconformance system Product corrections and removals, including health hazard evaluations Learning Management System (LMS) oversight and training strategy Quality Systems KPI reporting for Governance and Management Review Subject Matter Expert role during internal and external audits Mentorship and leadership of team members What you must have: Bachelor's degree in Engineering or a related science. Master's degree preferred 6+ years of medical device engineering, quality, or regulatory experience Experience with electronic QMS solutions (e.g. SmartSolve IQVIA, Cornerstone, Teamcenter) ASQ certification (or equivalent) in Medical Device Auditing Experience with PowerBI for data management and reporting Experience with software validation within a Quality Management System Strong knowledge of domestic and international Quality System regulations Proven ability to lead cross-functional teams and projects #J-18808-Ljbffr