Apply on Employer Site

TRIMEDX · 1 day ago

QRC Risk Management Analyst-CONTRACTOR

Indianapolis, IN

Full-time, Contract

Hybrid

Mid Level

$35/hr - $35/hr

3+ years exp

TRIMEDX is a company dedicated to serving clients, patients, and communities with a focus on care and performance. The QRC Risk Management Analyst is responsible for identifying, analyzing, and managing medical equipment maintenance program risk data, ensuring compliance with accreditation and regulatory standards.

Asset ManagementHealth CareHospital

H1B Sponsor Likely

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)

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

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

Qualification

Clinical engineeringData analysisRegulatory complianceISO 13485 auditingMicrosoft ExcelMicrosoft AccessWritten communicationVerbal communicationCreative thinkingSelf-motivated

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 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

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

Associate's degree in clinical engineering, Data Quality and/or Regulatory Compliance, Applied Science or Business equivalent or equivalent experience required

Preferred

Knowledge of healthcare industry, regulatory compliance, clinical engineering, medical technology, and/or healthcare support services preferred

Bachelor's degree preferred

Company

TRIMEDX

Glassdoor3.6

TRIMEDX is a provider of clinical engineering, medical device cybersecurity and clinical asset management solutions.

Founded in 1998

Indianapolis, Indiana, USA

1001-5000 employees

https://trimedx.com/

H1B Sponsorship

TRIMEDX has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (2)

2022 (2)

2021 (2)

2020 (2)