Noah Medical · 18 hours ago
Sr. Quality Engineer, Service and Customer Support
San Jose, California
Full-time
Hybrid
Mid, Senior Level
$108K/yr - $135K/yr
5+ years expNoah Medical is building the future of medical robotics, and they are seeking a Sr. Quality Engineer for their Service and Customer Support team. This role is responsible for establishing and supporting quality processes related to new product introduction, design transfer, and post-market support, ensuring compliance with FDA and ISO standards.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Support root cause analysis and corrective/preventive actions (CAPA)
Assist in developing, maintaining, and improving SOPs, Work Instructions, FMEAs and related quality documentation
Monitor and report Quality KPIs (e.g., NCR trends, Cost of Quality) and contribute to post market risk management activities
Ensure day to day compliance with FDA, ISO, and company quality standards
Support internal audits, inspections, and regulatory readiness
Collaborate with Customer Care, Field Service, and Product Support to help evaluate recurring service issues, product performance concerns, and maintenance challenges
Review service records and provide quality oversight in customer communication documentation
Provide tools, training, and documentation to ensure service teams can meet quality and compliance expectations
Assist in non-product software validation activities, including protocols, reports, and risk analyses
Participate in process improvements using Lean and Six Sigma methodologies
Partner with cross-functional teams (R&D, Manufacturing, Medical Education) to reduce recurring issues and improve serviceability
Communicate feedback from the field to inform design improvements and product reliability
Conduct quality reviews of new product launches and system integrations
Support clinical and technical training evaluations to ensure service teams are prepared
Coordinate with Sales, Marketing, and Training to align on customer-facing quality needs
Qualification
Required
Bachelor's degree in Engineering or related Science, or equivalent experience
5+ years in Quality Engineering, ideally in medical devices or robotics
Strong knowledge of GxP, FDA regulations (21 CFR Part 11), IEC 62353, and ISO standards (e.g., 13485, 60601)
Experience with CAPA, risk management, and validation (software and process)
Proficiency with quality and business systems (e.g., Salesforce, Arena, Jira, Tableau, MS Office)
Excellent communication, organizational, and problem-solving skills
Preferred
CQA or Six Sigma certification; project management experience
Experience with global product launch quality management
Benefits
Health insurance
401K
Stock purchase plans
Tuition reimbursement
Paid time off plus holidays
Flexible approach to work with remote, hybrid, field or office work schedules
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