Quality Assurance Manager

This is an on-site position in Bloomington, MN

Fasikl Inc. is an innovative medical technology company developing AI-driven neuromodulation solutions. Our lead product, the Felix™ NeuroAI™ Wristband, is FDA-cleared to aid in the management of functional limitations due to essential tremor. We are seeking an experienced and driven Manager of Quality Assurance to lead and evolve our quality systems across both pre-market and post-market phases. This role will be instrumental in ensuring that our devices meet the highest standards of safety, compliance, and performance as we scale development, manufacturing, and global commercialization.

Key Responsibilities

Pre-Market Quality Responsibilities

• Develop, implement, and maintain design controls , risk management (ISO 14971), and product development documentation in accordance with 21 CFR 820 and ISO 13485.
• Ensure effective design transfer to manufacturing and supplier quality oversight.
• Support clinical and regulatory teams with quality documentation for FDA, CE, and other submissions.
• Manage quality inputs during product development, including verification / validation protocols, usability studies, and labeling reviews.

Post-Market Quality Responsibilities

General Quality System Management

Qualifications

Why Join Fasikl