Quality Assurance Manager

This is an on-site position in Bloomington, MNFasikl Inc. is an innovative medical technology company developing AI-driven neuromodulation solutions. Our lead product, the Felixâ„¢ NeuroAIâ„¢ 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 ResponsibilitiesPre-Market Quality ResponsibilitiesDevelop, 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 ResponsibilitiesOversee complaint handling, investigation, and Medical Device Reporting (MDR).Manage CAPA processes, including root cause analysis and effectiveness checks.Lead post-market surveillance activities, including trend analysis and risk re-evaluation.Support audits and regulatory inspections by FDA, Notified Bodies, or other agencies.General Quality System ManagementMaintain and improve the company's Quality Management System (QMS)Lead internal audits and train teams on quality procedures and compliance culture.Evaluate and implement eQMS tools for scalable documentation control and traceability.Collaborate cross-functionally with R&D, clinical, operations, and regulatory teams.QualificationsBachelor's degree in engineering, life sciences, or a related field (Master's preferred)5+ years experience in medical device quality assurance (experience in similar devices a plus)In-depth knowledge of 21 CFR 820, ISO 13485, ISO 14971Strong understanding of both design controls and post-market quality systemsExperience preparing for or participating in FDA inspections or ISO auditsFamiliarity with eQMS platforms (e.g., Greenlight Guru, MasterControl, Veeva)Excellent project management and communication skillsPassion for innovation, compliance, and patient impactDesire to work in a dynamic, fast-paced environment.Maintain a strong commitment to ethics, professionalism, and integrity in all interactions.Commitment to Fasikl's mission of improving lives through cutting-edge neuro-AI technology and exceptional patient care.Why Join FasiklBe part of a mission-driven team pioneering a new era of AI therapeuticsContribute to the launch and scale-up of a first-in-class FDA-cleared productWork in a fast-paced, supportive startup environment with real patient impactCompetitive compensation, equity, and benefits

Created: 2025-10-02