1. Job Description

Axoft is building the most advanced and scalable platform for implantable brain-machine interfaces. Our mission is to enable long-term stable and ultra-high bandwidth communication with the brain, opening new therapies and treatments against neurological disorders and physical disabilities. We have bridged the gap between electronic and biological materials to create the softest brain implants in the world using our unique semiconductor fabrication technology. We are now looking to add a talented person to the team who is passionate, delivers results, is committed to finding creative solutions to complex engineering problems, and grow together with the company. Axoft is looking for candidates who have demonstrated exceptional abilities and results in their previous professional, academic and interpersonal experiences and have the skillset that fits this job offer.

We are seeking a highly skilled and experienced Quality Manager to join our dynamic startup team. This individual will be responsible for leading our Quality Management System (QMS) implementation, ensuring the highest standards of quality are met across all our medical devices, and overseeing the quality of our research products. The Quality Manager will also have an important role in the regulatory and clinical activities of the company. This person will report to the Director of Product Development. This position will be on-site at our various locations in Cambridge, MA.

2. Responsibilities

• Lead the implementation and maintenance of the Quality Management System (QMS) in compliance with applicable regulations and standards such as FDA QSR, ISO 13485, MDSAP, EU MDR, and ISO 9001.

• Develop, implement, and maintain quality policies, procedures, and processes to ensure medical device product quality, research product quality, and regulatory compliance.

• Oversee all quality-related activities, including product development, manufacturing, post-market surveillance, and research product development.

• Establish a culture of continuous improvement and operational excellence throughout the organization.

• Conduct regular quality audits and inspections, identifying areas of non-compliance and implementing corrective actions.

• Collaborate with cross-functional teams to drive quality considerations throughout the product lifecycle and research product development.

• Manage relationships with regulatory bodies and represent the company during quality audits and inspections.

• Monitor and report on quality performance metrics, providing regular updates to senior management.

3. Qualifications

• Bachelor’s degree in engineering, life sciences, or related field. Advanced degree preferred.

• Minimum of 10 years of experience in Quality Assurance within the medical device industry. Startup experience preferred.

• Proven experience in implementing and maintaining an electronic QMS in a regulated environment.

• Strong knowledge of medical device regulations and standards (FDA QSR, ISO 13485, MDSAP, EU MDR).

• Regulatory Affairs experience is a strong plus.

• Clinical trials experience, especially with early feasibility studies, is a strong plus.

• Experience managing the quality of research products under ISO 9001 is a plus.

• Excellent leadership and team management skills.

• Strong problem-solving abilities and attention to detail.

• Excellent communication and interpersonal skills.