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Nanobiosym is an innovative, high-tech company that is developing novel technologies at the nexus of physics, nanotechnology, and biomedicine. Founded by MIT/Harvard alum and located in Cambridge, Massachusetts, Nanobiosym was awarded the first X-Prize to be given for healthcare. The Compliance Engineer is responsible for the organization and the coordination of processes pertaining to regulatory compliance and quality systems to ensure regulatory requirements for compliance. This is a hands-on leadership position in a growing organization and an opportunity which will grow rapidly.
Job Responsibility:
Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps
Aid in Coordinating a production and Engineering Team in a variety of manufacturing processes
Develop and Implement new processes including DOE, IQ, OQ, PQ
Able to implement TAQ time analysis, life flow studies, and improvement plans in a ISO 13485 environment
Perform root cause analysis and help develop corrective actions
Develop and assist in the process and product monitoring, including the creation and documentation of validation protocols that comply with FDA regulations
Provide troubleshooting focus and direction for the team with details of root cause analysis
Utilizes DRM/COS/Lean principles to develop creative, thorough and practical technical solutions
Requirements:
Bachelor's degree is required in an Engineering - mechanical, polymer or material science discipline