Adecco Healthcare & Lifesciences is currently looking to fill remote Risk Management position for their client . **Job Title:** Risk Management SME **Shifts -8am to 5pm (M-F)** Pay -51.50-60.50/HR **Location:** Remote **Job Description:** Our client is looking to hire a highly experienced **Risk Management Subject Matter Expert (SME)** to join our Design Quality Assurance team. This role involves performing gap assessments, planning, executing, and reporting on usability and risk management activities in collaboration with cross-functional teams. The position is part of an EU MDR remediation project and will focus on ensuring compliance with relevant standards and regulations. **Key Responsibilities:** + Conduct comprehensive gap assessments of existing usability and risk management documentation against **EU MDR requirements** and standards such as **ISO 14971:2019** and **IEC 62366-1:2015** . + Provide leadership, expertise, and guidance in risk management throughout the remediation project. + Develop and implement robust processes, procedures, tools, and technologies to improve risk management practices. + Lead the development and monitoring of key performance indicators (KPIs) and metrics for risk management processes. + Support post-market surveillance teams by creating **Health Impact Assessments** and **Health Hazard Evaluations** . **Must-Have Skills:** + Strong experience with **ISO 14971:2019** (Risk Management for Medical Devices), including work performed after 2020. + Familiarity with **MDR requirements** and **IEC 62366-1:2015** . + Proven ability to remediate risk management files for **EU MDR compliance** . + Expertise in applying statistical techniques beyond process capability and SPC charts. Knowledge of **Minitab** is a plus. + Excellent communication and collaboration skills. + Ability to work during standard business hours. **Qualifications:** + Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical). + 5-7 years of experience in the medical device industry with expertise in risk management for all classes of medical devices. + In-depth knowledge of statistical techniques to calculate probabilities of hazardous situations (p1). + Advanced understanding of industry best practices in **Usability Engineering** and **Risk Management** . Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. **Pay Details:** $51.50 to $60.50 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance