Position Overview

The Manager, Quality Assurance will 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. This position reports to the President.

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

• Oversee 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 Management

• Maintain 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.

Qualifications

• Bachelor’s degree in engineering, life sciences, or a related field required; Master’s preferred.
• 5+ years in medical device quality assurance (experience in similar devices preferred).
• In-depth knowledge of 21 CFR 820, ISO 13485, ISO 14971.
• Strong understanding of both design controls and post-market quality systems.
• Experience preparing for or participating in FDA inspections or ISO audits.
• Familiarity with eQMS platforms (e.g., Greenlight Guru, MasterControl, Veeva).
• Excellent project management and communication skills.
• Passion for innovation, compliance, and patient impact.

Why Join Fasikl

• Be part of a mission-driven team pioneering a new era of AI therapeutics.
• Contribute to the launch and scale-up of a first-in-class FDA-cleared product.
• Work in a fast-paced, supportive startup environment with real patient impact.
• Competitive compensation, equity, and benefits.