Growing Medical Device company is seeking a Quality Engineer to support post market challenges. Looking for someone who has strong GD&T experience to focus on complaint handling and sustaining engineering change reviews.
· Support the maintenance and continuous improvement of the ISO 13485 quality management system processes.
· Prepare reports by collecting , analyzing and summarizing data regarding quality processes/product capabilities, problems and trends, and quality related design & development topics
· Lead the Corrective Action/Preventive Action process. Promote effective and timely resolution to quality problems with the focus on true root cause and verified corrective action.
· Serve as a Lead or Co-lead in the Internal Audit Process. Schedule and perform audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow-up and recommendations.
· Participate in external audits with ISO Registrar, Authorized Representative and other government agencies.
· Interface with ISO Registrar, Authorized Representative and government agencies, as necessary.
· Review and recommend improvements to the implemented Quality Management System (Quality Manual, Standard Operating Procedures and Work Instructions).
· Collect process metrics and lessons learned, review and evaluate processes and work products and recommend improvements as appropriate,
Location: Lewisville, TX