Teal Health
About Teal Health
Teal Health is on a mission to provide women with the tools, access, and resources they need to make their own, informed decisions regarding their health—starting with cervical cancer screenings. We’ve created the first FDA authorized at-home cervical cancer screening. We’re replacing the in-office pap smear with a cervical cancer screening that is comfortable, convenient, and designed for women. Teal Health’s solution includes a patented Teal Wand collection device and a modern telehealth platform to make it easy for women to speak with a doctor, screen at home and understand their results.
Our Values We boldly champion the future women deserve. And we do this through our values, which are to elevate women, expect exceptional, and learning, every day. The Teal team lives our values and uses them to guide our decisions when building Teal.
Why We Are Hiring As Quality Assurance Manager you will serve as the quality system lead for Teal Health’s Class II medical device (the Teal Wand) and maintain and continuously improve the QMS with focus on post‑market processes. If a candidate has regulatory compliance experience, the position could include responsibility for evaluation of design controls that impact Class II filing consideration and assistance/leadership of FDA filings, labeling review or product labeling and customer facing advertising.
Role Expectations & Responsibilities
Overall responsibility for the QMS (build, maintain, audit, improve, train)
Serve as Management Representative
Maintenance of the eQMS system (QT9)
Oversee annual training to QMS/QSR/ISO 13485 for all employees, maintain and ensure training compliance of all employees to applicable QMS procedures
Supplier qualification, including compliance of contract manufacturers, establishment and oversight of Quality Agreements, supplier audit cadence, including on‑site audits
Drive Post‑Market Surveillance and follow‑up activities
Ensure compliance to Design Control and Risk Management requirements (with functional teams)
Maintain and oversee Document Control
Oversee product testing including authoring, editing of test protocols, identify test lab(s) and oversee required testing, create and edit test reports
Oversee internal and external quality audits (performing in person or contracting to qualified auditor)
Interface with engineering and product as Quality representative
Assist in other regulatory / quality activities as assigned
Assist with regulatory compliance and preparation of quality‑related requirements for regulatory submissions
Drive a culture of continuous improvement, fostering innovation and quality enhancement in all aspects of the organization.
Success in the First 12‑18 Months
Structure Post Market Surveillance for newly acquired post market quality metrics – optimize data capture, analysis, and communication across the organization
Maintain and improve the QMS through timely audits (internally and externally conducted), corrective actions and process improvements with focus on post market SOPs
Ensure supplier performance and contract manufacturers and critical suppliers through metrics, monitoring, regular communication, including supplier visits and audits
Maintain and improve Teal employee training as the organization grows to ensure that employees understand QMS requirements and their roles in the QMS
Qualifications
7+ years experience in medtech or pharmaceutical QMS management and development
Responsibility for QMS oversight – monitoring and continuous improvement
Knowledge of applicable standards to medical device development, manufacture and compliance to regulations
Bachelor’s degree (required) in engineering or technical discipline (desirable)
Certified (Biomedical) Quality Auditor certification – a plus
Characteristics
Excellent interpersonal and communication skills (verbal and written)
Relationship management skills, across organization and with external suppliers
Detail oriented
Drives compliance within organization through education, flexibility and good humor
Passion, curiosity, growth mindset
Flexible, “can do”
Willing to take on projects to assist overall Teal mission
Benefits Offered
Equity Compensation
HSA / FSA
401K
Parental leave for eligible employees
Flexible PTO
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Our Values We boldly champion the future women deserve. And we do this through our values, which are to elevate women, expect exceptional, and learning, every day. The Teal team lives our values and uses them to guide our decisions when building Teal.
Why We Are Hiring As Quality Assurance Manager you will serve as the quality system lead for Teal Health’s Class II medical device (the Teal Wand) and maintain and continuously improve the QMS with focus on post‑market processes. If a candidate has regulatory compliance experience, the position could include responsibility for evaluation of design controls that impact Class II filing consideration and assistance/leadership of FDA filings, labeling review or product labeling and customer facing advertising.
Role Expectations & Responsibilities
Overall responsibility for the QMS (build, maintain, audit, improve, train)
Serve as Management Representative
Maintenance of the eQMS system (QT9)
Oversee annual training to QMS/QSR/ISO 13485 for all employees, maintain and ensure training compliance of all employees to applicable QMS procedures
Supplier qualification, including compliance of contract manufacturers, establishment and oversight of Quality Agreements, supplier audit cadence, including on‑site audits
Drive Post‑Market Surveillance and follow‑up activities
Ensure compliance to Design Control and Risk Management requirements (with functional teams)
Maintain and oversee Document Control
Oversee product testing including authoring, editing of test protocols, identify test lab(s) and oversee required testing, create and edit test reports
Oversee internal and external quality audits (performing in person or contracting to qualified auditor)
Interface with engineering and product as Quality representative
Assist in other regulatory / quality activities as assigned
Assist with regulatory compliance and preparation of quality‑related requirements for regulatory submissions
Drive a culture of continuous improvement, fostering innovation and quality enhancement in all aspects of the organization.
Success in the First 12‑18 Months
Structure Post Market Surveillance for newly acquired post market quality metrics – optimize data capture, analysis, and communication across the organization
Maintain and improve the QMS through timely audits (internally and externally conducted), corrective actions and process improvements with focus on post market SOPs
Ensure supplier performance and contract manufacturers and critical suppliers through metrics, monitoring, regular communication, including supplier visits and audits
Maintain and improve Teal employee training as the organization grows to ensure that employees understand QMS requirements and their roles in the QMS
Qualifications
7+ years experience in medtech or pharmaceutical QMS management and development
Responsibility for QMS oversight – monitoring and continuous improvement
Knowledge of applicable standards to medical device development, manufacture and compliance to regulations
Bachelor’s degree (required) in engineering or technical discipline (desirable)
Certified (Biomedical) Quality Auditor certification – a plus
Characteristics
Excellent interpersonal and communication skills (verbal and written)
Relationship management skills, across organization and with external suppliers
Detail oriented
Drives compliance within organization through education, flexibility and good humor
Passion, curiosity, growth mindset
Flexible, “can do”
Willing to take on projects to assist overall Teal mission
Benefits Offered
Equity Compensation
HSA / FSA
401K
Parental leave for eligible employees
Flexible PTO
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