Quality Systems Admin

Quality System Administrator

THE RIGHT CANDIDATE

We're looking for a creative, collaborative, resourceful, thoughtful, smart, entrepreneurial team member who has a passion for our mission and shares our values. The right candidate will thrive in a fast-paced environment, celebrate winning as a team and be resourceful in finding, creating and implementing solutions. They will balance moving swiftly and thoroughly with ensuring that they are contributing to our collaborative team environment. They will care equally about achieving excellent results and ensuring everyone involved feels a valued part of the team. This person will be a key ambassador for our company.

The successful candidate is a quick learner who will seek first to understand, work with the current team to get up to speed, utilize and synthesize work that has already been done to get up to speed quickly on the business. They must be comfortable in a start-up environment and thrive on finding creative solutions. There is no playbook outside of the mission we share and the values we embrace.

ROLE

This role is responsible for playing a key role on our quality team. The successful candidate has Quality Control and/or Quality Assurance experience in a regulated environment and eQMS experience, preferably Propel. This role is located in our Indianapolis, IN office.

• You will be responsible for coordinating and maintaining controlled documents via TMRW's Propel software system.
• You will be responsible for the training program related to quality management documents.
• You will be responsible for ensuring all documents are current, properly identified, and maintained per applicable standards and regulations.
• You will be responsible for reviewing records and documents for completeness and compliance with FDA Quality System Requirements, EU Medical Device Regulation requirements and ISO requirements.
• You will be responsible for receiving inspection per product specifications, material review and disposition.
• You will support the calibration program, the nonconforming product program and warehouse environment requirements.
• You will assist in the creation of controlled documentation and assist in training new hires.
• May be required to help with data integration during customer setups.
• Other duties as assigned.

You must be an enterprising self-starter, comfortable with ambiguity, and focused on flawless execution. You will win by turning ideas into action, strategy into tangible execution that will create value for TMRW and our customers. You will work closely with our Regulatory and Quality team.

WHAT YOU'LL NEED TO SUCCEED

• Bachelor's degree or equivalent work experience
• 2+ years of experience working in a regulated environment (medical device preferred but not necessary)
• Experience in an ISO 9001/ISO 13485 environment
• You are a curious collaborator and strong team player

ABOUT US

TMRW Life Science's mission to safeguard life's most precious cells. We design technology that provides safety and transparency to modernize and transform IVF. Our platform revolutionizes the management, identification, tracking, storage and care of frozen eggs and embryos used in IVF. Developed in partnership with leading fertility doctors and embryologists, TMRW's technology will play a central role in the births of tens of millions of people in the coming years by setting a new standard of care in the IVF industry.

Our team includes many pioneering leaders in clinical medicine, reproductive biology, embryology, and cryogenic biobanking who have synthesized their collective knowledge, vision, and experience in the development of the TMRW platform. We're committed to bringing together a diverse, cross-disciplinary team to achieve our mission - and we're always looking for more innovators to join us in creating a better tomorrow.

At TMRW, we know that cultivating diversity and fostering an inclusive work environment is critical to our impact and success. We create an environment where no individual is advantaged or disadvantaged because of their background. We offer equal opportunity employment regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, marital status, or protected veteran status.

With a commitment to maintaining a bias-free environment where harassment is prohibited, we respect cultural diversity and comply with the laws of the places we operate. We expect our business partners, suppliers, clients, and team members to uphold these commitments.

We look for people who share our values. They are our promise to each other and the guideposts for our day-to-day work.

Our TMRW values:

Integrity is our non-negotiable.

Excellence is our standard.

Collaboration is how we win.

Trailblazing is our spirit.

Service is our passion.

Care is at the heart of everything we do.