Quality & Regulatory Specialist

Overview

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.

Position The Quality and Regulatory Specialist is responsible for providing guidance and support to the TRIMEDX Field Operations team to assure that they maintain a robust, standardized, and effective Quality Management System which complies with applicable regulatory and quality standards. The Quality and Regulatory Compliance Program includes but is not limited to quality internal audits and regulatory survey support, 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.

Location
:
Indianapolis, Indiana; candidates must currently reside in the central Indiana region; within a 70 mile range of our Indianapolis central office. Position is Hybrid: work from home, work in-office 1x per week & ability to travel up to 30% as needed.

• Relocation is not available for this position
• Immigration sponsorship not available for this position

Regulation Research and Education Support (25%)

• 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 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 Service Now…