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TRIMEDX · 1 day ago

Quality & Regulatory Compliance Analyst - CONTRACTOR

Indianapolis, IN

Full-time, Contract

Hybrid

Mid Level

$35/hr - $35/hr

3+ years exp

TRIMEDX is a company focused on serving clients and communities with care and performance. The Quality and Regulatory Compliance Analyst-CONTRACTOR role involves producing compliance data for audits and ensuring adherence to accreditation standards and regulations through data analysis and reporting.

Asset ManagementHealth CareHospital

Responsibilities

Conduct targeted analysis of repair and preventive maintenance data related to QRC internal audits and data audits criteria to ensure compliancy to federal state and local regulations and accreditation standards

Compile data and perform analysis for equipment make/models/description and modalities, as well as equipment risk to ensure standardized MMD creation, maintenance and improvement

Support Quality and Regulatory Specialists with reporting criteria and analysis of effectiveness verification post audit and CAPA completion

Identification, monitoring and assistance with risk/opportunity assessment across the organization

Provide oversight, monitoring and analysis with regulatory compliance requirements

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

Conduct analysis and comparison of alerts and recalls in determining impact to TRIMEDX organization and timely closure of loop

Monitor, measure and produce QRC reporting necessary for Quality Management Review on a monthly/quarterly basis

Support Quality and Regulatory Specialists with reporting criteria during site inspections and surveys

Lead QMS internal audit activities (per ISO 13485, 27001 and/or applicable regulatory standards)

Create, manage and monitor PM Transition Plan and Tools for new site implementations and existing sites with PM compliancy gaps

Based on data analysis results and organizational feedback; partner with cross functional areas when the development of new processes, products, services, or relationships is required

Develop best practices and business rules to ensure uniformity in work, deliverables and outcomes

Assist with creation, analysis and maintaining standardized reporting of Pilgrim CAPA progress and effectiveness verification

Creation, maintenance and improvement of data audit and remote internal audit tool for QRC team and external field facing documentation

Participate in AEM (Alternative Equipment Maintenance) and PM Variance Committee by producing pertinent data pull and analysis related to PM Frequency Change and AEM Program requests and speak to outcome of 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 mitigation of risks to patient safety and compliance

Demonstrate competency as a QRC subject matter expert for RSQ and QMS software program analysis

Assist with prompt response and actions related to QRC ServiceNow requests (PM Frequency Changes, PM Not Needed Requests, AEM Program Review, Bulk QRC requests)

Collaborate with cross functional business leaders to capture and document QRC reporting and analytics needs

Create and deliver QRC presentation data support and communications to peers, functional area leaders, and executives

Collaborate with QRC team and Field Operations to ensure timely deliverables requested on behalf of surveyor during regulatory and accreditation survey process

Participate in PM Variance and AEM Committees to share QRC analysis with group to drive outcomes based upon compliancy

All other duties as assigned

Qualification

Data analysisRegulatory complianceQuality management systemsMicrosoft ExcelISO standards knowledgeChange managementCommunication skillsProblem solvingCreative thinking

Required

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

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

Basic knowledge and application of ISO 13485, 9001 and/or 27001 standards and applicable regulations

Strong analytical and 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

Change management and customer focused

Associates degree in Quality and/or Regulatory Compliance, Clinical Engineering, Applied Science or Business equivalent or equivalent experience required