Senior Manager, Quality

About Us

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.

We are currently focused on two programs: a first-of-its-kind neural interface to transform recovery after stroke and pioneering direct bladder stimulation therapy for underactive bladder.

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 neurotechnologies into the clinic and closer to patients.

The Role

We are seeking a Senior Manager of Quality to lead our quality function and drive quality excellence across the organization. This individual will be responsible for designing and scaling our Quality Management System (QMS) and leading key quality areas including document control, design assurance, and supplier quality. They will be instrumental in embedding quality activities throughout the entire product development lifecycle and ensuring compliance with Class III medical device standards.

This role is ideal for someone who thrives in a fast-paced, early-stage environment and knows how to apply the right level of process at the right time—balancing compliance with practicality. You’ll guide teams through complex regulatory requirements while building flexible, stage-appropriate systems.

What You’ll Do

• Select, implement, and manage the company’s Quality Management System (QMS) platform.

• Develop and scale quality processes that evolve with the organization from early development through first-in-human.

• Lead design quality and assurance activities for new product development, ensuring compliance with class III medical device standards

• Drive implementation and maintenance of design control processes, including design planning, design reviews, verification & validation, and design transfer.

• Lead risk management activities in accordance with ISO 14971, including hazard analysis, and risk-benefit assessments.

• Oversee document control systems and quality records to support traceability, audit readiness, and continuous improvement.

• Manage supplier qualification and implement secondary supplier controls to maintain a compliant and resilient supply chain.

• Partner cross-functionally with R&D, Regulatory, Clinical and Operations teams to provide pragmatic, stage-appropriate quality guidance that enables innovation.

What We’re Looking For

• 8+ years of experience in the medical device industry, with a focus on advancing Class III products from early feasibility through first-in-human (FiH) trials.

• Proven track record in selecting and implementing Quality Management Systems (QMS).

• Demonstrated expertise in design controls, risk management, and supplier quality with deep knowledge of ISO 13485, FDA 21 CFR Part 820.

• Proven ability to select, implement, and scale Quality Management Systems (QMS) in growing R&D organizations.

• Collaborative partner who works effectively across engineering, regulatory, clinical, operations, and medical sciences teams.

• Hands-on, adaptable leader who brings structure and clarity to evolving environments and drives results amid ambiguity.

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 scal tomorrow.