Quality System Administrator
Current• Support an ISO 9001 and ISO 13485 compliant Quality Management System.• Oversee day to day activities of the Quality Management System in fulfillment of company directives, policies and ISO standard requirements.• System Administrator for Quality Management System (QMS).• Coordinate Quality Management System document control process that allows for efficient and controlled access to current approved documents.• Track and coordinate documentation change requests, from approval through implementation.• Assist with maintaining quality documentation such as training records, SOPs, audit files, validation documentation, etc. Including reviewing, scanning, filing, and indexing of documents.• Monitor and track training of MMI employees to ensure training process is compliant. • Prepare, create, or update reports and documents, as requested in support and with input from process owners.• Train MMI employees on MMI Quality System procedures.• Assist in developing training materials such as PowerPoint presentations and quizzes for company-wide procedures and processes to document effectiveness of training.• Assist in tracking quality management system metrics in support of the company’s Quality Objectives.• Assist in maintaining the MMI corrective and preventive action systems and support MMI personnel in developing appropriate corrective actions for observed gaps or non-conformances.• Assist in scheduling, facilitating, preparing and documenting the Management Reviews.• Participate in the internal audit program which includes development of the internal audit schedule, prepare and conduct internal audits, summarize audit findings and report into MMI’s corrective/preventive action program and at the Management Review/s.• Coordinate and host sponsor, regulatory and registrar audits. Assist with MMI audit responses.• Support Director of Regulatory and Quality Affairs with any quality related tasks and objectives in support of departmental or company functions.
