Noah Medical · 4 hours ago
Recalls & CAPA Manager
San Jose, California
Full-time
Hybrid
Mid, Senior Level
$127K/yr - $159K/yr
7+ years expNoah Medical is building the future of medical robotics, focusing on early diagnosis and treatment of patients. The Recalls & CAPA Manager will play a crucial role in managing CAPA processes, overseeing product recalls, and ensuring regulatory compliance to enhance quality management systems.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Develop and maintain the CAPA process to investigate and resolve product, process, or service nonconformities. This includes identifying root causes and implementing corrective actions
Manage product recall processes from initiation to completion, ensuring timely and effective communication with regulatory bodies and the public
Lead and coordinate CAPA / Recalls / Project teams to achieve quality objectives and regulatory compliance
Report on quality metrics and CAPA performance to all levels of the organization
Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements
Stay up-to-date on global regulations and industry standards related to complaints, recalls, and quality systems
Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations
Qualification
Required
Bachelor's degree in an engineering discipline; advanced degree preferred
Minimum of 7 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO)
Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485
Experienced in conducting internal audits and hosting 3rd party audits
Good understanding of the medical device design, manufacturing, and field service processes
Self-starter, team builder, and excellent in verbal and written communication
Preferred
Experience working in a startup environment as well as larger commercial medical device companies
Knowledge of sterile/disposable medical device production processes
Certifications are a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc
Benefits
Competitive Salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, 15-20 days of PTO + sick time
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Company
Noah Medical
Noah Medical develops medical robotics using its next-generation robotic platform for patient diagnosis and treatment.
201-500 employees
H1B Sponsorship
Noah Medical 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 (16)
2024 (21)
2023 (11)
2022 (11)
2021 (5)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
$150M2023-04-19Series B· $150M
Leadership Team
Jian Zhang
CEO, Founder
Recent News
2025-05-04
2025-04-03
2025-04-02
Company data provided by crunchbase