Recalls & CAPA Manager at Noah Medical

San Jose, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Robotics, Healthcare, MedTechIndustries

Requirements

Bachelor's degree in an engineering discipline; advanced degree preferred
Minimum of 7 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO)
Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485
Experienced in conducting internal audits and hosting 3rd party audits
Good understanding of the medical device design, manufacturing, and field service processes
Self-starter, team builder, and excellent in verbal and written communication
Preferred: Experience working in a startup environment as well as larger commercial medical device companies
Preferred: Knowledge of sterile/disposable medical device production processes
Certifications are a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc

Responsibilities

Develop and maintain the CAPA process to investigate and resolve product, process, or service nonconformities, including identifying root causes and implementing corrective actions
Manage product recall processes from initiation to completion, ensuring timely and effective communication with regulatory bodies and the public
Lead and coordinate CAPA / Recalls / Project teams to achieve quality objectives and regulatory compliance
Report on quality metrics and CAPA performance to all levels of the organization
Support defining, training, and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure proper documentation and revision for continued compliance with US and International regulatory requirements
Stay up-to-date on global regulations and industry standards related to complaints, recalls, and quality systems
Regularly interact 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 in sensitive situations

Skills

CAPA Management

Root Cause Analysis

Corrective Actions

Recall Management

Regulatory Compliance

FDA Standards

Quality Metrics Reporting

Cross-functional Leadership

Quality Management Systems

Process Optimization

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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