Quality Assurance Manager

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 for this role:
As Quality Assurance Manager (Quality/Regulatory, if qualifications align) you will serve as the quality system lead for Teal Health's Class II medical device (the Teal Wand) and maintenance and continuous improvement of Teal Health's FDA QSR and ISO 13485 compliant quality management system. You will maintain and improve the QMS, train employees, and oversee supplier compliance. This role requires QMS expertise and the ability to adapt and grow with the organization. You will be the key quality interface across functions in the organization. Teal Health is scaling commercially so this person needs to maintain and continuously improve the QMS with focus on the post-market/scaling processes.

If a candidate has experience in regulatory compliance, the position could include responsibility for evaluation of design controls that impact Class II filing consideration and assistance/leadership of those FDA filings, in addition to 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 compliance across 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 include
:

Equity Compensation

HSA / FSA

401K

Parental leave for eligible employees

Flexible PTO