Cora is a modern women’s wellness brand infusing good into a category rife with unhealthy products and outdated notions of womanhood.
At Cora, we believe women and their bodies are naturally powerful, so we make naturally powerful goods for the body, that are good for her body, while doing good in the world.
Our mission is to revolutionize the female experience by acknowledging the natural power of female bodies and providing healthy, thoughtful ways to care for them. We create fearless content and innovative products through an elevated brand to shift the way women perceive and manage their periods, bladder leaks, post-birth recovery, and other natural experiences. And with every Cora purchase, we provide period pads and health education to a girl in need in a
developing country so she can step boldly into the promise of her future. After just three years in market, Cora has achieved the highest brand equity in the $6B U.S. Feminine Care category. As Cora continues to scale–in terms of products, channels, and revenue–we are seeking an experienced Quality Manager who maintains a detailed focus on establishing and maintaining quality procedures and controls to meet regulatory and ISO 13485 requirements for Class II medical devices.
Who We are Looking For:
The ideal candidate will be someone who is not afraid of rolling up their sleeves and logging lots of data into our quality database. Someone humble enough to tackle low level mundane tasks some days and then drive high-level strategic discussions the next. Someone who is hungry to learn and take on more responsibility as the company grows.
This role demands someone who connects with our mission, cares about women’s health, and is driven by a desire to do work with a purpose. You will need to be a quick study and willing to learn and adapt in a fast-paced, dynamic, start-up environment, taking on a high degree of responsibility and autonomy. The role will report into the Senior Director of Operations.
Responsibilities:
• Manage the Quality Management System to ensure compliance with applicable medical
device standards and FDA regulations.
• Plan, schedule and conduct internal and/or external (supplier) quality system audits.
• Review and update the QMS: scope, policy, manual and procedures to assure compliance with ISO and regulatory requirements that drives continuous improvements as required.
• Cooperate with management personnel in formulating and establishing company policies,
procedures, objectives and goals
• Develop and lead quality programs on-boarding training for new employees
• Maintain up to date records within internal systems (complaint tracking, CAPAs, etc.)
Create structure for consumer quality testing.
• Own new product specification sheets and coordinate with manufacturer to ensure product quality compliance.
About You
• A Creative Problem Solver – Continuous improvement mindset with demonstrated ability to
identify and implement process improvements to eliminate non-value-added work
• An Action Oriented Doer – Someone who is driven by results. Someone who strongly believes in accountability. A task-oriented self-starter who stays calm under pressure and proactively takes on big ideas and projects.
• A Collaborator – One who works well with teams and can listen while still sharing a strong point of view.
• An Optimist – Someone with a can-do attitude, who can lead in the face of uncertainty, and with a great sense of humor.
Qualifications:
• A minimum of 2 years Quality Assurance and Quality Systems, experience in the drug or
medical device industry is a plus
• Knowledge of ISO 13485
• Direct experience with Internal / External Audits
• Expertise with Document Control, SOPs, Change Control, CAPA, FDA Regulations
• Excellent communication skills (written and oral) • Time management skills and the ability to prioritize various work-streams
• Proven ability to collaborate effectively with business partners.
To be considered for this opportunity you must be documented to work in the United States and reside in the Bay area. You will be working at our San Francisco office during normal working hours. Cora offers competitive salary and benefits, an amazing team and a world-changing mission.