Quality Assurance Specialist & Cross-Functional Liaison

CoreMap Inc.; Burlington (MA); Teletrabalho; USD 75 000 - 95 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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

Responsabilidades

• 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.

Conhecimentos

Written and verbal communication

Quality systems

Cross-functional collaboration

Formação académica

Bachelor’s Degree in a technical discipline

Ferramentas

SolidWorks

QMS software

CAD drawings & BOMs

Descrição da oferta de emprego

Quality Assurance Specialist & Cross-Functional Liaison

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

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