QualitySystemsManager

Bachelor's degree or higher in business or STEM discipline from an accredited university, 7+ years of relevant experience in ISO 13485 and FDA GMP, Experience with gap analysis and management of quality system standards changes, Experience in business case creation, selection, implementation, validation, and/or sustainment of electronic enterprise Quality Management System software programs, Experience aligning quality management systems across multiple facility locations, collaborating and building relationships with local site management representatives, Experience with the full range of ISO 13485 and FDA GMP, as it is associated to Class II and III medical device design, manufacturing, servicing, and distribution, Experience writing, changing, and auditing company/site level quality managing system procedures, compliant with ISO 13485 and FDA GMP, Experience managing and assuring the effectiveness of Management Review for US site, Experience managing and assuring the effectiveness of CAPA processes/systems for US site, Experience managing and assuring the effectiveness of global Document Control and Engineering Change Control processes, Experience managing and assuring the effectiveness of Complaint/Feedback processes, Experience managing and assuring the effectiveness of Quality System Audit (internal, customer, regulators) processes, 2+ years of experience managing a team, formally or informally, Excellent Written & Oral Communication Skills, Experience with configuration of reports, security/access, data structuring, meta-data fields, and workflows in Product Lifecycle Management (PLM) systems, Excellent skills in standard computer-based software programs, Excellent skills in data analysis to report and present effectiveness of business processes