Job Details

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 healthstarting with cervical cancer screenings. Weve created the first FDA authorized at-home cervical cancer screening. Were replacing the in-office pap smear with a cervical cancer screening that is comfortable, convenient, and designed for women. Teal Healths 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 Healths 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
• Bachelors 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