Quality Assurance Specialist & Cross-Functional Liaison

CoreMap; Burlington (MA); Remote; USD 85,000 - 125,000; Full time

Job summary

CoreMap is pioneering real-time 3D electroanatomical mapping for atrial fibrillation, combining medical devices with advanced data science. The QA Specialist & Cross-Functional Liaison will drive QMS processes across Engineering, Quality, Clinical, and Regulatory, ensuring documentation is complete and accurate while supporting supplier programs and audits.

This role offers full-time remote or in-person work.

Qualifications

• BS degree in a technical field required.
• Familiar with ISO 13485, FDA QMSR and 21 CFR Part 11 preferred.
• Experience with QMS software and basic workflows.
• Proficiency in SolidWorks; read engineering drawings, BOMs, specs.
• Strong verbal/written communication; explain quality concepts to engineers.
• Comfortable in fast-paced startup and regulated later-stage environments.

Responsibilities

• Serve as liaison across Engineering, Quality, Clinical, and Regulatory.
• Coordinate documentation and process activities to meet quality requirements.
• Support supplier approvals, change requests, and audits.
• Prepare document packages including CAD drawings, BOMs, labeling.
• Maintain QMS records and logs for process owners.
• Assist in training and process guidance development.
• Support audit preparation and evidence gathering.

Skills

Communication skills

Cross-functional liaison

QMS familiarity

Reading drawings

Education

Bachelor’s degree in technical field

Tools

SolidWorks

QMS software tools

Job description

At CoreMap, 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.

Responsibilities

• 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.

Skills and Experience

• 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 SolidWorks; 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