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

Key technologies and capabilities for this role

CAPAFMEARoot Cause AnalysisSOPsWork InstructionsQuality KPIsNCRFDA ComplianceISO StandardsInternal AuditsRisk ManagementSoftware Validation

Questions & Answers

Common questions about this position

What qualifications are required for the Sr. Quality Engineer role?

Candidates need a Bachelor’s degree in Engineering or related Science, or equivalent experience, plus 5+ years in Quality Engineering ideally in medical devices or robotics. Required knowledge includes GxP, FDA regulations (21 CFR Part 11), IEC 62353, and ISO standards like 13485 and 60601, along with experience in CAPA, risk management, and validation.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or is there a location requirement?

This information is not specified in the job description.

What is the company culture like at Noah Medical?

Noah Medical features an incredibly talented team of engineers, innovators, and industry leaders with experience from top healthcare companies like Intuitive, Auris, and Stryker, focused on revolutionizing robotic surgery with motivated and ambitious team members.

What makes a strong candidate for this Quality Engineer position?

A strong candidate has 5+ years in Quality Engineering in medical devices or robotics, strong knowledge of FDA and ISO regulations, and hands-on experience with CAPA, risk management, validation, and process improvements using Lean and Six Sigma.

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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