If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance.
- 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
It is truly a culture like no other - We hope you will join our team! Find out more about our company and culture here .
Summary
The QRC Risk Management Analyst is responsible for identifying, analyzing, and managing medical equipment maintenance program risk data criteria, performing risk assessments, and complying with accreditation and regulatory standards. This position will ensure regulatory compliance by analyzing, monitoring, and maintaining risk management processes related to Alternative Equipment Maintenance (AEM), Manufacturer / Model / Description (MMD) Categorization, Preventive Maintenance (PM) Variances, and End of Life / End of Service (EOL / EOS) data throughout the lifecycle of TRIMEDX medical equipment inventory.
Responsibilities
QRC Risk Management and Compliance Program (80%)
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.QRC Risk Management Collaboration (20%)
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.Skills and Experience
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.Education and Qualifications
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.At TRIMEDX, we support and protect a culture where diversity, equity and inclusion are the foundation. We know it is our uniqueness and experiences that make a difference, drive innovation and create shared success. We create an inclusive workplace by actively seeking diversity, creating inclusion and driving equity and engagement.
We embrace people's differences which include age, race, color, ethnicity, gender, gender identity, sexual orientation, national origin, education, genetics, veteran status, disability, religion, beliefs, opinions and life experiences.
Visit our website to view our full Diversity, Equity and Inclusion statement, along with our social channels to see what our team is up to : Facebook , LinkedIn , Twitter .
TRIMEDX is an Equal Opportunity Employer. Drug-Free Workplace.
Because we are committed to providing a safe and productive work environment, TRIMEDX is a drug-free workplace. Accordingly, Associates are prohibited from engaging in the unlawful manufacture, sale, distribution, dispensation, possession, or use of any controlled substance or marijuana, or otherwise being under the influence thereof, on all TRIMEDX and Customer property or during working / on-call hours.
