Sequel Quality Manager Remote · Full time

Who we are: Founded by two award-winning Stanford engineers and former athletes, Greta Meyer and Amanda Calabrese, Sequel™ is re-engineering feminine healthcare products - starting with the tampon. At Sequel™ we believe that women are never truly prepared for their most critical moments because their health products weren't built for them. We're a lean, agile team committed to creating products that support modern, active women who are breaking barriers and shattering glass ceilings.

Description

Who we are looking for:


We are looking for an experienced Quality Manager with a strong medical device background, preferably within a startup environment, to be our first Quality hire. The Quality Manager will create and execute the quality initiatives for multiple feminine healthcare products at various stages in the lifecycle. This role will also design, implement, manage, and execute all quality processes ensuring compliance with all regulatory requirements. If you embrace the ambiguity that comes with a small but growing startup, love learning, thinking outside of the box, and collaborating with a motivated and talented team, we would love to hear from you!


What you will do:


  • Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, registration, and manufacturing of FemCare products.
  • Create quality strategies and documents to ensure compliance with all current and emerging US and global regulations.
  • Support Engineering and manufacturing product validations, testing, and other efforts.
  • Serve as the Management Representative to regulatory agencies in addition to developing effective professional relationships with them.
  • Design, implement, manage, and execute the Quality Management System and its processes ensuring compliance with all regulatory requirements.
  • Develop, implement, manage, and update policies, processes, and SOPs to support quality and regulatory compliance.
  • Perform risk analysis to identify potential and emerging risks and create mitigation strategies.
  • Manage and support the audit process for both internal and external audits.
  • Manage processes involved with maintaining annual licenses, registrations, and listings.
  • Handle and resolve all customer complaints including executing CAPAs as needed.
  • Other duties as assigned


What Skills Will Help You Be Successful:


  • 3+ years of quality experience in an FDA-regulated industry; medical device experience required
  • Past Experience as a Quality team of 1
  • Strong bias for action and ownership
  • Strong problem-solving skills and ability to see the downstream effects of strategy decisions
  • High level of organization
  • Exceptional written and verbal communication skills
  • Strong collaboration, team-first mentality, prioritization, and adaptability skills required
  • Extremely comfortable with change, ambiguity, and uncertainty as we strive for innovation over perfection.
  • Ability to pivot and adapt to quickly changing product goals
  • Thrives in a high-energy, start-up environment


Benefits and Perks:


  • Salary $75,000 - $90,000 + equity
  • This is a fully remote position
  • 401K
  • Unlimited PTO
  • Health Insurance
  • Paid Holidays
  • Flexible Schedule


Sequel™  is an equal opportunity employer. We're excited to work with talented, innovative people, and do not discriminate based on race, color, sex, gender identity or expression, sexual orientation, religion, national origin, physical or mental disability, military or veteran status, genetic information, pregnancy, age, or any other status protected by law.


Research shows that women and other minority groups only apply to open roles if they meet 100% of the listed criteria. Sequel encourages everyone — including women, people of color, individuals with disabilities, and those in the LGBTQIA+ community — to apply for our available positions, even if they don't necessarily check every box on the job description.



Salary

$75,000 - $90,000 per year