Remote QA Specialist & Cross-Functional Liaison

CoreMap Inc.; Burlington (MA); Remote; USD 75,000 - 95,000; Full time

Job summary

CoreMap Inc. is revolutionizing atrial fibrillation treatment with real-time 3D electroanatomical mapping. We seek a Quality Assurance Specialist & Cross-Functional Liaison to ensure QMS processes run efficiently while maintaining meticulous documentation.

You will partner with Engineering, Quality, Clinical, and Regulatory teams in a fast-paced startup that also adheres to stringent regulatory standards. The role supports supplier programs, change control, training, audits, and quality

Qualifications

• 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 reading engineering drawings/BOMs

Responsibilities

• Serve as a liaison across Engineering, Quality, Clinical, and Regulatory, ensuring quality requirements are understood and documentation is completed.
• Support supplier approvals/evaluations, document change requests, training, and audit activities.
• Coordinate supplier documentation and input to support supplier qualification, monitoring, and issue resolution.
• Work with engineers to prepare document change packages including CAD drawings, BOMs, and product labeling.
• Initiate and process document change requests per document control procedures.
• Coordinate training activities and maintain training records; assist in developing practical process guidance.
• Support internal and external audit preparation, evidence gathering, and act as an internal auditor.
• Collaborate with quality engineers to improve workflows and templates for scalable QMS.
• Maintain QMS records/logs (change requests, nonconformances, suppliers, equipment, training).
• Assist in implementing manufacturing/production processes and closing documentation gaps.
• Contribute to monitoring quality objectives and KPI reporting with data inputs.
• Provide engineering support for product documentation and ensure traceability.

Skills

Written and verbal communication

Quality systems

Cross-functional collaboration

Education

Bachelor’s Degree in a technical discipline

Tools

SolidWorks

QMS software

CAD drawings & BOMs

Job description

CoreMap Inc. is revolutionizing atrial fibrillation treatment with real-time 3D electroanatomical mapping. We seek a Quality Assurance Specialist & Cross-Functional Liaison to ensure QMS processes run efficiently while maintaining meticulous documentation.

You will partner with Engineering, Quality, Clinical, and Regulatory teams in a fast-paced startup that also adheres to stringent regulatory standards. The role supports supplier programs, change control, training, audits, and quality