SPECTRAFORCE · 21 hours ago
Manager Risk Management
Massachusetts, United States
Contract
Hybrid
Senior Level
5+ years expSPECTRAFOR is seeking a Risk Management Subject Matter Expert to join their Design Quality Assurance team. This role involves conducting gap assessments and leading risk management activities while collaborating with cross-functional teams to ensure compliance with relevant standards.
ConsultingCRMInformation TechnologyLegal
Hiring Manager
Nivedika Verma
Responsibilities
Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015
Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project
Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management
Leads development and implementation of key performance indicators and metrics for the risk management process
Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations
Qualification
Required
Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)
5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices
Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1)
Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology
Company
SPECTRAFORCE
Welcome to SPECTRAFORCE, your gateway to NEWJOBPHORIA™! Established in 2004, SPECTRAFORCE is now one of the largest and fastest growing U.S.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase