iota Biosciences, Inc. powered by Astellas · 1 day ago
Quality Manager - Neurological Therapies
Alameda, CA
Full-time
Onsite
Senior Level
$150K/yr - $190K/yr
5+ years expiota Biosciences, a subsidiary of Astellas Pharma US, is advancing bioelectronic medicines through innovative medical devices. The Quality Manager role involves establishing and managing quality systems for implantable neurotechnology, partnering with engineering and clinical teams to ensure compliance and quality throughout the development process.
BiotechnologyLife ScienceMedical
Responsibilities
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
Qualification
Required
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
Preferred
Startup or small company experience strongly preferred
Company
iota Biosciences, Inc. powered by Astellas
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company working to develop pioneering bioelectronics to advance the treatment and management of disease.
51-200 employees
H1B Sponsorship
iota Biosciences, Inc. powered by Astellas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (15)
2023 (6)
2022 (11)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$15M2020-10-15Acquired
2018-12-27Series A· $15M
Leadership Team
Michel Maharbiz
Chief Executive Officer
Recent News
Google Patent
2025-05-05
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2025-05-05
2025-05-05
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