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MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. Description Manage, audit, and improve Neuronetics' ISO 13485 certified, QSR compliant Quality System to ensure continuous improvement and maintained QMS compliance. Lead the post-market surveillance and complaint assessment, investigation, and closure activities including trending, escalation, and remediation activities. Own all aspects of the CAPA process. Review and approve Change Notices. Collect, trend and report on Quality System metrics for presentation at Management Review and Post Market Surveillance. Knowledge, Skills and Abilities: Strong technical writing skills. Strong communications and team building skills for use at all levels of the organization. Ability to manage multiple priorities and triage accordingly. Thorough knowledge of ISO 13485 Standard and 21 CFR 820 Regulations and their application. Solid understanding of the PM Surveillance, Complaint Handling, CAPA, and remediation processes. Working knowledge of statistical techniques for data analysis. Advanced use of MS Office, Adobe, NetSuite, and SharePoint. Minitab a plus. Education and Experience: A Bachelor's Degree in a related area of concentration. Approximately 3-5 years of demonstrated Quality Engineering success in a Medical Device company with an FDA and ISO regulated Quality Management System. Experience with internal audit practices. ASQ certification a plus. Leading Medical Device company focused on developing non-invasive therapies for psychiatric and neurological disorders. Competitive pay Benefits Growing team
