Noah Medical · 16 hours ago
Director, Quality Assurance and Regulatory Affairs
San Jose, CA
Full-time
Hybrid
Director/Executive
$201K/yr - $251K/yr
10+ years expNoah Medical is building the future of medical robotics, focusing on early diagnosis and treatment of patients. They are seeking a Director of Quality Assurance and Regulatory Affairs to lead the RA/QA function, manage staff, and ensure compliance with regulatory requirements throughout product development.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones
Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect
Manages the RA/QA department functions through direct reports or subordinates
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
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
Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions
May serve as the designated Management Representative
Qualification
Required
Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc
Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
Minimum of 3 years of supervisory experience of multiple exempt level employees
Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams
Experienced in implementing a complete QMS system to meet US FDA and ISO requirements
Experienced in conducting internal and supplier audits and hosting 3rd party audits
Must be a self-starter, team builder, and excellent in verbal and written communication
Preferred
Knowledge of sterile/disposable medical device production processes
Master Degree, MBA, experienced with Software Validation
Certifications is 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
Founder and CEO
Recent News
2025-05-04
2025-04-03
2025-04-02
Company data provided by crunchbase