• Quality & Regulatory Specialist I

    Location US-IN-Indianapolis
    Job ID
    2018-8238
    Category
    Quality/Regulatory Compliance
    Company Name
    TriMedx, LLC
  • Overview

    The Quality and Regulatory Compliance Specialist I is responsible for supporting and assisting Clinical Engineering Operations quality and regulatory readiness. This position is responsible for providing assistance and support of the Quality and Regulatory Compliance Program inclusive of audit assistance, risk analysis, monitoring and tracking of CAPA findings, as well as adherence to company policies and procedures to ensure patient safety. The ability of the business to meet its objectives and to remain compliant depends on the output and reliability of the day-to-day operation of Quality and Regulatory Compliance. As such, the Quality and Regulatory Compliance Specialist I must be able to continually adapt to changing business requirements and demand.

    Responsibilities

    • Track submission of TRIMEDX standardized Medical Equipment Management Plan (MEMP), as well as track Clinical Engineering site MEMP and Annual Assessment
    • Provide compliance training support for new and existing site managers and technicians
    • Provide support and updates for Regulatory and Accreditation Agency changes pertaining to TRIMEDX services:
    • Federal (FDA, CLIA, CMS), State (s) Department of Health and Human Services
      • Accreditations:Ambulatory Surgery Centers (AAAHC, AAAASF, TJC)Calibration (NIST, ACLASS, A2LA)
      • Modality (Laboratory – CAP, AABB; Imaging – ACR, NRC)
      • Hospitals (TJC, HFAP, DNV)
      • Safety (Radiation, Laser, NIST, ANSI, NFPA, OSHA, Life Safety)
      • All other regulations and standards as applicable
    • Provide support to Quality & Regulatory Readiness program to ensure CE program sites are compliant with regulations and standards prior to inspections
    • Provide TRIMEDX PolicyStat program support and guidance for policy and procedure creation and revision
    • Monitor, analyze and generate Alerts and Recalls pertaining to medical devices within the TRIMEDX Inventory for patient safety and compliance
    • Review, monitor and communicate monthly PM variances to the field
    • Assist with monitoring and follow up of potential patient/medical device incident program (Safe Medical Device Act)
    • Assist with providing best practices for TRIMEDX Operational processes in effort to mitigate risk
    • Support and assist Alternative Equipment Maintenance Program (AEM)
    • Support and assist with on-site Clinical Engineering audits to mitigate risk to patient safety
    • Support and ensure adherence to TRIMEDX Policies and Procedures
    • Conduct data analysis of Clinical Engineering Site performance of repairs, PM, and management of alerts and recalls, to maintain compliance and support audit activities
    • Creation, monitoring and managing CAPAs, resulting from audit findings
    • Provide support to standards and metrics that drive operations performance

    Qualifications

    • Bachelor’s degree in a related healthcare field, applied science or clinical engineering required
    • Minimum of 1- 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 policy and procedure management and best practices
    • Basic database entry skills
    • Ability to participate in multiple projects in a team environment
    • Proven analytical and problem-solving skills to diagnose and resolve issues
    • Basic knowledge of Microsoft Office applications required
    • Organization and time management skills
    • Strong written, verbal, and presentational communication skills
    • Conflict management skills

     

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