TRIMEDX · 1 day ago
Quality & Regulatory Specialist
Indianapolis, IN
Full-time
Hybrid
Entry, Mid Level
1+ years expTRIMEDX is dedicated to serving clients and communities with care and performance. The Quality and Regulatory Specialist is responsible for supporting the Field Operations team by ensuring compliance with quality management systems and regulatory standards, including conducting audits and managing compliance programs.
Asset ManagementHealth CareHospital
No H1B
Responsibilities
Manage, monitor and update TRIMEDX standardized Medical Equipment Management Plan (MEMP), as well as track Clinical Engineering site submission of MEMP and Annual Assessment
Provide compliance training support for new and existing site managers and technicians
Provide support and updates for Quality, Regulatory and Accreditation Agency changes pertaining to TRIMEDX services:
ISO 13485 standards
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 Compliance program to ensure Field Operations sites are compliant with quality standards and regulatory requirements
Provide support and guidance for the QMS documentation
Monitor, analyze and generate Alerts and Recalls pertaining to medical devices within the TRIMEDX computerized maintenance management system (CMMS)
Review, monitor and communicate monthly PM variances to the field
Assist with managing, 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 with Alternative Equipment Maintenance Program (AEM)
Support and assist with Field Operations Internal audits to mitigate risk to patient safety (train and develop to be a lead auditor)
Support and ensure adherence to TRIMEDX Policies and Procedures
Monitor and support Field Operations Site performance of repairs, PM, and management of alerts and recalls, to maintain compliance and patient safety
Creation, monitoring and managing CAPAs, resulting from audit findings
Provide support to standards and metrics that drive operations performance
Provide telephone/remote support to Field Operations team
Partner with TRIMEDX Field Operations teams 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
Ability to travel when required – 30%
All other duties as assigned
Qualification
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
Basic to intermediate Excel skills; with ability for data reporting and analysis
Conflict management skills
Bachelor's degree or equivalent experience in a related healthcare field, applied science or clinical engineering required. (Associates degree considered in combination with direct experience requirement)
Company
TRIMEDX
TRIMEDX is a provider of clinical engineering, medical device cybersecurity and clinical asset management solutions.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$0.2M2014-01-21Debt Financing· $0.2M
Leadership Team
Neil de Crescenzo
Chief Executive Officer
Christopher Dunkerley
CFO
Recent News
2025-09-17
Company data provided by crunchbase