QRC Risk Management Analyst-CONTRACTOR

• Everyone is focused on serving the customer and we do that by collaborating and supporting each other
• Associates look forward to coming to work each day
• Every associate matters and makes a difference

• Conduct QMS internal data audit activities (per ISO 13485 and/or applicable regulatory standards) related to AEM, MMD, EOL/EOS and PM Variance.

• Monitor and measure equipment service trending related to risk, perform gap assessments, and share recommendations with QRC leadership to ensure compliance to regulatory and quality standards.

• Maintain standardized and normalized medical equipment categorization (Make, Model, Description – MMD) and set-up processes to meet organizational requirements.

• Assist with MMD matching of new and existing customer inventory in accordance with TRIMEDX MMD standardization processes and best practices .

• Obtain and evaluate technical information from equipment manufacturers, contract specifications, service manuals, and historical data for risk analysis and mitigation related to preventive maintenance strategies. Accurately interpret the information and utilize as an input to PM strategies within the TRIMEDX CMMS database.

• Collaborate, maintain, and update equipment data to capture useful life of medical equipment in the TRIMEDX inventory database and provide supporting data for replacement cycles (End of Life/End of Service).

• Monitor and conduct analysis of the inputs and outputs of the TRIMEDX AEM program, MMD equipment set up, end of life and end of service documentation and notifications, as well as variances in Preventive Maintenance (PM) frequencies.

• Maintain and update the medical equipment manuals library in the CMMS database to ensure operational efficiencies and regulatory compliance.

• Provide support to QRC team with reporting criteria and analysis of effectiveness of TRIMEDX preventive maintenance program frequencies.

• Identification, monitoring and measuring of program risk assessments across the organization.

• Review data and systems for errors, anomalies, and other inconsistencies, and develop and implement processes to improve data integrity and quality.

• Conduct data analysis and identify patterns and trends.

• Utilize data analysis results and organizational feedback to partner with cross functional areas when the development of new processes, products, services, or relationships is required.

• Participate in AEM (Alternative Equipment Maintenance) and PM Variance Committee by producing pertinent data and analysis related to PM Frequency Change and AEM Program requests. Provide input regarding the data analysis to committee members to drive decision making processes related to equipment risk and PM frequencies.

• Monitor, measure and communicate compliancy gaps and risks in a timely manner to ensure patient safety and mitigation of potential compliance risks.

• Assist with prompt response and actions related to QRC ServiceNow requests (PM Variance, PM Not Needed Requests, AEM Program Review, MMD Creation, End of Service Life).

• Create and deliver QRC Risk Management process education, presentations, data support, and communications to peers and functional leaders throughout the organization (I.E. AEM, MMD, EOL/EOS, PM Variance).

• Work with key stakeholders to identify root cause of risks and collaborate to resolve them.

• All other duties as assigned.

• Minimum of 3 years of experience in clinical engineering, quality, compliance, with demonstrated competency in data analysis, reporting, and application of problem solving.

• Experience in analysis and trending of quality and regulatory processes required.

• Knowledge and experience in conducting and/or leading internal audits (ISO 9001, 13485 standards preferred).

• Experience with complex reporting and analysis to ensure QRC data integrity and compliancy.

• Strong demonstrated proficiency with Microsoft Office applications; advanced skills with Advanced Excel and Access required.

• Knowledge of healthcare industry, regulatory compliance, clinical engineering, medical technology, and/or healthcare support services preferred.

• Strong analytical and regulatory standards interpretation skills to understand complex regulations and data analysis related to compliancy.

• Strong written and verbal communication skills supporting interactions with personnel at all levels within the organization.

• Creative thinker with ability to meet stringent and changing deadlines with accuracy.

• Self-motivated with a change management mindset.

• Associate’s degree in clinical engineering, Data Quality and/or Regulatory Compliance, Applied Science or Business equivalent or equivalent experience required.

• Bachelor’s degree preferred.

TRIMEDX