Quality Assurance Manager

Teal Health(2 months ago)

San Francisco, CAOnsiteFull TimeManager$95,637 - $127,157 (estimated)Clinical, Regulatory & Quality

About this role

The Quality Assurance Manager at Teal Health leads the quality management system for the FDA-authorized Teal Wand, a Class II medical device for at-home cervical cancer screening. Responsibilities include maintaining and improving the QMS in compliance with FDA QSR and ISO 13485 standards, overseeing supplier compliance, conducting audits, and driving post-market surveillance. This role requires expertise in medical device regulatory compliance and an ability to foster a culture of continuous improvement within the organization as it scales.

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Required Skills

Quality Management System
Quality Audits
Regulatory Compliance
Supplier Qualification
Post-Market Surveillance
Document Control
Design Control
Risk Management
Employee Training
Continuous Improvement

+6 more

Qualifications

Bachelor’s degree in engineering or technical discipline
Certified (Biomedical) Quality Auditor certification

About Teal Health

www.getteal.com

Teal Health is dedicated to revolutionizing women's healthcare by providing a more convenient and private option for cervical cancer screening. Their flagship product, the Teal Wand™, is the first FDA-authorized device that allows for at-home cervical cancer screening, enabling women to collect samples comfortably in their own environment. Teal Health's mission emphasizes ease of use, accessibility, and supportive virtual medical care, aiming to increase screening rates and improve women's health outcomes. Additionally, the company collaborates with major insurance providers to ensure affordability and accessibility for all women.