• Quality & Regulatory Specialist II

    Location US-IN-Indianapolis
    Job ID
    Quality/Regulatory Compliance
    Company Name
    TriMedx, LLC
  • Overview

    The Quality & Regulatory Compliance Specialist II is responsible for conducting research, interpretation, education and adherence to Clinical Engineering (CE) accreditation standards and regulations (state, federal and local).  The position is responsible for execution of a Total Quality Management and Regulatory Compliance Program inclusive of executing CE site and desk audits, CAPA issuance and effectiveness verification, medical device alert and recall management, patient/equipment incident management, AEM program management, and adherence to Clinical Engineering Policies and Procedures.  The ability of the business to meet its objectives and to remain compliant depends on the output and reliability of the day-to-day operations of the Quality and Regulatory Compliance team. As such, the Quality and Regulatory Specialist II must be able to continually adapt to the evolving Regulatory landscape and demands.


    • Monitor and update TRIMEDX standardized Medical Equipment Management Plan (MEMP), as well as track Clinical Engineering (CE) site submission of MEMP and Annual Assessment
    • Assist with creation and execution of compliance training for new and existing site managers and technicians
    • Research, monitor, evaluate and interpret Regulatory and Accreditation Agencies for changes pertaining to TRIMEDX services (Federal, State, Accreditations, Safety)
    • Provide education and support for the Quality and Regulatory Readiness program to ensure CE program sites are compliant with regulations and standards in effort to mitigate patient safety risk
    • CE Operational policy and procedure interpretation and education
    • Monitor, analyze and generate Alerts and Recalls pertaining to medical devices within the TRIMEDX Inventory for patient safety and compliance
    • Maintain and update the Compliance Connection which is cascaded to TRIMEDX Operations in effort to remain current on Clinical Engineering Quality, Supplier Quality and Regulatory Compliance
    • Conduct analysis of Clinical Engineering Site performance of repairs, preventative maintenance, and management of alerts and recalls, to maintain compliance and perform audit activities
    • Conduct on site and/or desk audits of Clinical Engineering Sites to mitigate risk to patient safety
    • CAPA issuance and monitoring for non-conformance issues identified during the audit
    • Conduct effectiveness verification of completed CAPAs to ensure execution
    • Partner with TRIMEDX Implementation Team to support new customer onboarding and/or existing customers


    • Bachelor’s degree in a related healthcare field, applied science or clinical engineering required
    • Healthcare quality and/or regulatory audit experience is a plus
    • Minimum of 3 years of experience in clinical engineering, healthcare quality, compliance, risk, or medical device industry
    • Basic knowledge and experience interpreting Clinical Engineering or Healthcare regulations and standards
    • Working knowledge of policies, procedures and best practices
    • Working knowledge of healthcare services and risk management
    • Ability to participate in multiple projects in a team environment
    • Proven analytical and problem-solving skills to diagnose and resolve issues
    • Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred)
    • Organization and time management skills
    • Ability to multitask
    • Strong written, verbal, and presentational communication skills
    • Conflict management skills
    • Excellent presentation skills


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