Quality Assurance Specialist & Cross-Functional Liaison

At Core Map, we are innovating at the intersection of medical devices and advanced data science to improve outcomes for people affected by atrial fibrillation. We are developing a next-generation, real-time 3D electroanatomical mapping system for use in complex cardiac procedures. By leveraging advanced statistical analysis on data acquired from our proprietary ultra-high-resolution catheter, we generate unprecedented maps of AFib that empower physicians to deliver highly targeted therapy.

The QA Specialist & Cross-Functional Liaison serves as a practical liaison across Engineering, Quality, Clinical, and Regulatory, helping teams execute Quality Management System (QMS) processes efficiently while maintaining complete and accurate documentation. The role supports the supplier program, document change requests, training, operations/production, audit activities, and quality performance reporting. This is a full-time remote or In-person role

Serve as a liaison across Engineering, Quality, Clinical, and Regulatory, helping teams understand applicable quality requirements and coordinate timely completion of documentation and process activities

Support quality engineers in the execution of supplier approvals/evaluations, document change requests, training, and internal/external audit activities

Coordinate supplier documentation and engineering input to support supplier qualification, monitoring, and resolution of supplier-related issues

Work with engineers to prepare complete document and design change packages, including affected component specifications (including CAD drawings), BOMs, product labeling

Initiate and process document change requests in accordance with established document control procedures

Coordinate assigned training activities, maintain training records, and support development and delivery of practical process guidance

Support internal and external audit preparation, evidence gathering, and follow-up; participate as an internal auditor

Partner with quality engineers to improve workflows, templates, and documentation practices that support a scalable and effective QMS

Maintain QMS records and logs (document change requests, nonconformance reports, suppliers, equipment, training) in support of process owners

Support implementation of operations/production processes, maintain required records, and resolve documentation or process gaps

Participate in monitoring quality objectives and KPI reporting by coordinating inputs and checking data

Provide support to engineering teams for product documentation

Drive scalable best practices compatible with a development stage company

Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes.

Bachelor’s Degree or higher in a technical discipline

Familiarity with ISO 13485, FDA QMSR (21 CFR 820), and 21 CFR Part 11 preferred

Experience with QMS software tools and building simple workflows

Experience with Solid Works; ability to read and navigate engineering drawings, BOMs, and specifications

Excellent verbal and writing skills, with the ability to explain quality requirements in practical terms to engineers

Comfortable working in both a fast-paced and rigorous early-stage startup environment, as well as a regulated later-stage, process-driven setting

Salary range: $75,000 - $95,000