Quality Assurance Manager

Teal Health•San Francisco, CA

About The Position

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. 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.

Requirements

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)
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

Nice To Haves

Certified (Biomedical) Quality Auditor certification a plus

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.