Quality & Regulatory Specialist I

If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance. Everyone is focused on serving the customer and we do that by collaborating and supporting each other Associates look forward to coming to work each day Every associate matters and makes a difference It is truly a culture like no other - We hope you will join our team! Find out more about our company and culture here. 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. Location: Indianapolis, Indiana Central Office. Our Central (Corporate) Office is located on the northwest side of Indianapolis. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Responsibilities Regulation Research and Education Support (25%) Track submission of TRIMEDX standardized Medical Equipment Management Plan (MEMP), as well as track Clinical Engineering site MEMP and Annual AssessmentProvide compliance training support for new and existing site managers and techniciansProvide 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:Hospitals (TJC, HFAP, DNV) Ambulatory Surgery Centers (AAAHC, AAAASF, TJC) Modality (Laboratory - CAP, AABB; Imaging - ACR, NRC) Calibration (NIST, ACLASS, A2LA) 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 Compliance Program Support (25%) 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) Audit and CAPA Support (25%) 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 Operations Support (25%) Partner with TRIMEDX Operations to onboard and new and existing customers by: Resolution of unmatched devices Provide Quality & Regulatory Compliance, support and documentation Report PM frequency variance for like and kind MMD Provide support for PM load balancing and PM schedule adjustments Support and resolve Quality and Regulatory Compliance ServiceNow Tickets Travel: Ability to travel as required, approximately 20% Qualifications Education and Work Experience 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 Knowledge 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 At TRIMEDX, we support and protect a culture where diversity, equity and inclusion are the foundation. We know it is our uniqueness and experiences that make a difference, drive innovation and create shared success. We create an inclusive workplace by actively seeking diversity, creating inclusion and driving equity and engagement. We embrace people's differences which include age, race, color, ethnicity, gender, gender identity, sexual orientation, national origin, education, genetics, veteran status, disability, religion, beliefs, opinions and life experiences. Visit our website to view our full Diversity, Equity and Inclusion statement, along with our social channels to see what our team is up to: Facebook , LinkedIn , Twitter . TRIMEDX is an Equal Opportunity Employer. Drug-Free Workplace. Because we are committed to providing a safe and productive work environment, TRIMEDX is a drug-free workplace. Accordingly, Associates are prohibited from engaging in the unlawful manufacture, sale, distribution, dispensation, possession, or use of any controlled substance or marijuana, or otherwise being under the influence thereof, on all TRIMEDX and Customer property or during working/on-call hours.

Created: 2025-03-09