Quality Manager
6 days ago
iota Biosciences, a wholly owned subsidiary of Astellas Pharma US, is advancing a new class of bioelectronic medicines through the development of fully implantable Class III medical devices. Our proprietary technologies open therapeutic and diagnostic possibilities not previously accessible to clinicians.
Together with Astellas, we are committed to patient-centric design, scientific and engineering excellence, and cross-functional teamwork. These principles guide us in bringing transformative, first-of-its-kind technologies into the clinic and closer to patients.
The Role
We are seeking a Quality Manager to own and build the quality function for our implantable neurotechnology therapy. This is a highly hands-on role for someone who wants to shape quality systems from the ground up and partner closely with engineering, regulatory, and clinical teams in a fast-paced, early-stage environment.
You will design and implement lean, stage-appropriate Quality systems and practices, lead design assurance and risk activities, management, and ensure the foundational quality processes are in place as we advance toward Early Feasibility Studies (EFS).
This role is ideal for someone who has experience in risk-based activities , who can pragmatically apply the right level of process at the right time, and who wants meaningful ownership without needing a large team.
What You'll Do
- Select, implement, and manage all Quality activities, including building a right-sized Quality Management System (QMS) for an early-stage Class III medical device program.
- Build and scale quality processes that evolve from feasibility clinical studies and beyond.
- Lead Quality design and assurance activities, partnering closely with engineering to ensure design inputs, outputs, V&V, and design transfer are compliant with Class III requirements.
- Own risk management processes (ISO 14971), including hazard analysis and FMEAs in partnership with engineering and clinical teams.
- Oversee document control systems and ensure strong traceability and audit-readiness.
- Manage supplier qualification, onboarding, and supplier control.
- Support and lead CAPA, nonconformance investigations, and root-cause analysis.
- Partner cross-functionally with R&D, Regulatory, Clinical, and Operations to embed quality into daily development in a practical, enabling way.
- Serve as the primary quality resource-setting direction while executing the day-to-day work.
- 5+ years of quality experience in medical devices.
• 2+ years of Class III or active implantable experience required.
• Strong working knowledge of ISO 13485, 21 CFR 820, and ISO 14971.
• Hands-on experience with design controls, risk management, supplier qualification, and document control.
• Experience implementing or supporting an eQMS in a growing R&D organization.
• Strong communicator and collaborator with the ability to work effectively across technical and non-technical teams.
• Comfortable operating in early-stage, resource-constrained environments; able to build processes while executing them.
• Startup or small company experience strongly preferred.
Why This Role Is Unique
This position is ideal for someone who wants to build, not inherit- to set the direction for a world-class quality system while remaining close to the work itself. As our first dedicated Quality leader, you'll shape how we operate today and lay the foundation for how we scale tomorrow.
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