Senior Manager, Product Quality - Medical Device

New York, NY or Remote /
Medical Affairs /
Full-time
/ Hybrid
Who We Are
Ro is a direct-to-patient healthcare company providing high-quality, affordable healthcare without the need for insurance. Ro is the only company to seamlessly connect telehealth, in-home care, diagnostics, labs, and pharmacy services nationwide. This is enabled by Ro's vertically integrated platform that powers a personalized, end-to-end healthcare experience from diagnosis, to delivery of medication, to ongoing care. Since 2017, Ro has facilitated more than eight million digital healthcare visits in nearly every county in the United States, including 98% of primary care deserts. Visit Ro.co for more information.

Ro was named #2 in Wellness on Fast Company's 2019 list of the World's Most Innovative Companies, recognized as a CNBC Disruptor 50 in 2022, listed by Inc. Magazine as a Best Place to Work in 2022 for our third consecutive year, and named one of FORTUNE's 2022 Best Medium Workplaces.

The Role
As a Senior Manager for Product Quality, you will work on the Product Quality team assisting with the maintenance of a Quality Management System that complies with Federal and State regulations. In this role, you will help manage Quality Control and Quality Assurance processes across Ro’s products (Medical Devices, OTCs and Supplements, Compounding Pharmacies). You will lead cross functional teams for regulatory submission preparation related to products. You will partner closely with your Product Quality peers along with the subject matter experts (SMEs) across the organization to help draft Standard Operating Procedures (SOPs) and other necessary controlled documents. You will also help manage employee training , ensuring each team has necessary training logs for new and existing personnel. This role will also be responsible for the management of quality processes including CAPAs, Deviations, and Audits.

What You’ll Do:

    • Leads the development, implementation and maintenance of robust quality programs / Quality Management Systems, including Document Management / Retention, Personnel Training, and quality events
    • Partner with the legal and compliance team to ensure compliance with relevant regulatory statutes and guidance including FDA 21 CFR 820, USP 3, 795, 800 and 1163, FDA Guidance and MOU documents, regulations and requirements for all 50 states
    • Support future product regulatory submissions, including but not limited to FDA 510ks and other Premarket Approval submissions
    • Support product / process validations by working cross functionally with R&D and department level stakeholders to ensure proper documentation and retention of validation initiatives
    • Ensure day-to-day operations at internal facilities comply with all quality standards
    • Conduct initial and routine vendor audits to ensure compliance and quality standards are being met by our partners
    • Act as a member of the internal audit team to help successful execution of internal audit schedules
    • Serve as a member of Ro’s 3rd party audit team and help maintain audit readiness across Ro
    • Stay abreast of changing industry requirements

What You’ll Bring:

    • Bachelor's degree in biology, chemistry, or biochemistry
    • 6+ years of cGMP Quality Assurance / Quality Control experience in a regulated environment
    • 3+ years of Medical Device experience
    • Previous role as a participant on a team that successfully implemented a Quality Program / Quality System across an organization
    • Experience with 510k submissions, preferred
    • Ability to travel up to 20% of time for  vendor and internal audits
    • Experience with FDA regulations and inspections
    • Strong attention to detail and ability to think strategically and tactically
    • Six Sigma or other quality improvement certifications, strongly preferred
    • Outstanding written and verbal communication skills
    • Irrational passion for building the future of healthcare with an emphasis on quality processes to drive success patient outcomes.

We’ve Got You Covered:

    • Full medical, dental, and vision insurance + OneMedical membership
    • Healthcare and Dependent Care FSA
    • 401(k) with company match
    • Flexible PTO
    • Wellbeing + Learning & Growth reimbursements
    • Paid parental leave + Fertility benefits
    • Pet insurance
    • Student loan refinancing
    • Virtual resources for mindfulness, counseling, fitness, and physical therapy
The target base salary for this position ranges from $138,600 to $175,500, in addition to a competitive equity and benefits package (as applicable). When determining compensation, we analyze and carefully consider several factors, including location, job-related knowledge, skills and experience. These considerations may cause your compensation to vary.

Ro recognizes the power of in-person collaboration, while supporting the flexibility to work anywhere in the United States. For our Ro’ers in the tri-state (NY) area, you will join us at HQ on Tuesdays and Thursdays. For those outside of the tri-state area, you will be able to join in-person collaborations throughout the year (i.e., during team on-sites).

At Ro, we believe that our diverse perspectives are our biggest strengths — and that embracing them will create real change in healthcare. As an equal opportunity employer, we are committed to building an inclusive environment where you can be you.

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