Quality Manager

CoreMap’s mission is to improve the lives of people affected by atrial fibrillation. We are developing a high-resolution, real-time, 3D electroanatomical mapping system for use during cardiac procedures to guide ablation therapy. Our system will generate novel maps of AF using advanced statistical analysis of data acquired from our ultra high-resolution cardiac catheter.

We are looking for an experienced Quality Manager to lead and scale our Quality Assurance department within a dynamic and complex engineering environment. This role is based full time in our Burlington, MA office. The Quality Manager will be responsible for overseeing the Quality Management System (QMS), driving regulatory compliance strategy, and managing a team of quality professionals (including Principal Quality Engineers) through the final stages of product development and into commercialization.

Responsibilities

• Oversee and direct Quality Engineering during design phase activity including development, verification, validation, transfer, and associated design reviews for new product development and product realization.
• Direct and manage risk management activity, ensuring proper analysis and documentation are applied throughout the product development process.
• Provide strategic quality leadership to the design engineering teams for software, data science, and hardware/systems throughout the design control process and Software Development Life Cycle (SDLC).
• Oversee sustaining engineering through operational quality activity, including material control, process development, inspection/acceptance activity, CAPA nonconforming material control, equipment qualification, supplier management, and internal audit.
• Manage personnel and resources to inspect and test materials, equipment, processes, and products to ensure quality specifications are met.
• Design, implement, and maintain quality system processes to comply with regulatory standards.
• Direct cross-functional personnel training for quality and compliance best practices and proactively mentor QA team members.
• Oversee internal audit activity, including leading the strategic preparation and organizational readiness for external ISO 13485 certification.
• Drive the expanding understanding of applicable external standards across the organization to scale compliance in preparation for product commercialization.
• Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes.

Skills and Experience

• Bachelor's degree in mechanical or biomedical engineering or related applicable engineering field.
• A minimum of 10 years of experience in quality engineering or a related role in a regulated industry, with proven experience in a leadership or managerial capacity.
• Broad experience managing quality for software, data science, hardware/systems design and productions, or with similar medical devices, while working within a Quality Management System.
• Expert applied understanding of 21 CFR 820, ISO 13485:2016, and IEC 62304:2006.
• Demonstrated leadership experience overseeing the product development lifecycle, SDLC, design controls, and risk analysis.
• Excellent communication skills, good documentation practices (formal protocols and reports), attention to detail, and project management skills.