TRIMEDX is looking to identify, analyze, and manage medical equipment maintenance program risk data criteria, perform risk assessments, and ensure compliance with accreditation and regulatory standards.
Requirements
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.
Responsibilities
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).
Other
This role is for a Contractor, for a fixed duration of time, and will be contracted though our third-party vendor partner agency.
Position is hybrid (a mix of in-office, remote, as well as required business travel
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.
