Sr. Quality Engineer, Service and Customer Support at Noah Medical

San Jose, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Robotics, HealthcareIndustries

Requirements

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
Preferred: Experience with global product launch quality management

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

Skills

CAPA

FMEA

Root Cause Analysis

SOPs

Work Instructions

Quality KPIs

NCR

FDA Compliance

ISO Standards

Internal Audits

Risk Management

Software Validation

Noah Medical

Develops medical robotic solutions for pulmonology

About Noah Medical

Noah Medical creates medical robotic solutions to improve early diagnosis in pulmonology. Their main product, the Galaxy System™ with TiLT+ Technology™, enhances diagnostic accuracy by providing real-time navigation and an augmented fluoro feature for locating lesions. The system is designed for efficiency with a single-use bronchoscope that reduces cross-contamination risks and improves workflow. Noah Medical stands out by collaborating with leading pulmonologists to ensure their technology meets practical clinical needs.

Redwood City, CaliforniaHeadquarters

2018Year Founded

$145.9MTotal Funding

SERIES_BCompany Stage

Robotics & Automation, HealthcareIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Mental Health Support

Legal Services

Pet Insurance

12+ Paid Holidays

15-20 Days of PTO

Paid Parental Leave

In-office Snacks and Beverages

In-office Lunch Stipend

Learning & Development Opportunities

Team Building and Company Organized Social Events

Hybrid Work Options

Risks

Increased competition from established companies like Intuitive Surgical in robotic bronchoscopy.

Potential delays in regulatory approvals could impact market entry and sales.

High cost of the Galaxy System™ may limit adoption in smaller healthcare facilities.

Differentiation

Noah Medical's Galaxy System™ offers real-time navigation updates for lung procedures.

The system's single-use bronchoscope reduces cross-contamination and improves procedural efficiency.

Compact design of the Galaxy System™ suits crowded bronch suites and operating rooms.

Upsides

Growing demand for minimally invasive procedures aligns with Noah Medical's focus.

Rising investment in healthcare technology startups offers funding opportunities for Noah Medical.

Advancements in AI enhance real-time image processing in Noah Medical's robotic systems.

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