Head of Quality

Philadelphia, PA /Remote OK      ·    Full-Time

Nia Therapeutics is developing implantable brain stimulation devices to restore memory function after brain injury and degenerative disease. Our technology was developed at the University of Pennsylvania with funding from DARPA and our team has demonstrated proof of concept for improving human memory across multiple clinical studies. Our technology has the potential to help patients by improving their memory function, reducing disability and increasing on-the-job performance. Our team includes leaders in the fields of biomedical engineering, cryptography, neuroscience, and neurosurgery.

Job Summary

We are looking for a hands-on head of quality to develop our smart, connected neurostimulation platform for treating memory impairment. The successful applicant will play a key role in taking the company’s implantable medical device from an engineering prototype to clinical evaluation and will work closely with multi-functional engineering teams and executive staff. The Head of Quality will gain a deep understanding of the system requirements and architecture, develop our quality management system, oversee manufacturing at our partner organizations, and contribute to the development of regulatory applications to FDA.

Basic Qualifications

• BS in Engineering or life sciences; advanced degree desirable
• 5+ years of QA experience in the medical device or medical equipment manufacturing industry
• Demonstrated knowledge of ISO 13485, ISO 14971, ISO 9001, 21CFR820 standards and regulations
• Demonstrated ability to lead the development of a strong Quality Management System
• Demonstrated ability to communicate ideas in a coherent, compelling, way and to influence key stakeholders, including senior leadership of the company

Preferred Skills

• Experience establishing and maintaining a Quality Management System for a Class III device
• Experience with eQMS software
• Completed training on the current ISO 13485 standard
• Experience managing FDA or notified body audits
• Experience preparing regulatory submissions for Class II or III medical devices
• Excellent attention to detail, critical thinking and analytical abilities
• Demonstrated decision-making and problem-solving skills
• Ability to identify potential problems and take appropriate action
• Strong time management and organizational skills with the ability to prioritize your workload to meet deadlines
• Ability to thrive in a start-up, fast-paced, ever-changing work environment and be comfortable navigating the “grey”

Location

Nia Therapeutics has offices in the Greater Boston and Greater Philadelphia areas. Remote work possible. Must be eligible to work in the US.