Director, Quality Assurance and Regulatory Affairs at Noah Medical

San Jose, California, United States

Noah Medical Logo
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Robotics, HealthcareIndustries

Skills

Key technologies and capabilities for this role

Quality Management System (QMS)Regulatory AffairsQuality AssuranceMedical Device RegulationsStaff ManagementBudget ManagementPolicy DevelopmentCross-functional CollaborationProblem-SolvingCommunication

Questions & Answers

Common questions about this position

What experience is required for the Director of Quality Assurance and Regulatory Affairs role?

Candidates need a BS preferably in Engineering or Technology with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc., a minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus), and a minimum of 3 years of supervisory experience of multiple exempt level employees.

What does the RA/QA team structure look like at Noah Medical?

The Director of RA/QA reports to the Head of Quality and manages the RA/QA department functions through direct reports or subordinates, including staff hiring, assignments, performance feedback, and coaching.

What is the compensation or salary for this position?

This information is not specified in the job description.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What qualities make a strong candidate for this Director role?

Noah Medical seeks a highly motivated self-starter who is excellent in communication, a team builder focused on career growth (vertical and horizontal), and skilled in using soft skills to collaborate, problem-solve, and interact with senior management, suppliers, and customers.

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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