The Quality Assurance (QA) Specialist will be responsible for daily QA operations for TMRW Life Sciences, Inc. The QA Specialist will work remotely and will have responsibilities at client facilities, vendor facilities, and at the New York headquarters. The QA Specialist reports directly to the Quality & Regulatory Affairs Manager.
Key Duties & Responsibilities:
Internal and external audit execution
Daily maintenance of the Quality Management System
Perform Risk Assessments
Investigate Nonconformance Reports and Customer Complaints
Manage the Training Program
Assist with documentation for regulatory filings
Develop the company’s Disaster Recovery Plan
Participate in the Material Review Board
Oversight of equipment qualifications
Prepare monthly and quarterly metrics
Approximately 30% domestic travel
Other duties as assigned
Minimum of four years’ experience in a regulated industry, preferably medical device
Minimum of four years’ experience in a Quality Assurance role with decision-making responsibilities
Minimum of a bachelor’s degree in a Life Sciences field
ASQ Certification preferred
ISO 9001 and/or ISO 13485 experience preferred
FDA, EU MDD/MDR, and/or Health Canada experience preferred
Skilled in Root Cause Analysis and FMEA techniques
Skilled in technical writing
Skilled in Microsoft Word, Microsoft Excel, and Microsoft PowerPoint
Energetic, highly motivated, and results-driven
Strong organizational skills, attention to detail, ability to prioritize and multi-task
About TMRW Life Sciences, Inc.
Developed in partnership with leading fertility doctors and embryologists, TMRW’s technology significantly reduces risk to the precious and fragile cells and tissues used in IVF. Our robotic process automation radically improves the identification, freezing and storage of reproductive cells and embryos—putting an end to the error-prone manual and analog methods that have gone unchanged since IVF was first used in animal husbandry more than fifty years ago. Our automation eliminates 20% of the time required to perform manual tasks in the embryology lab, allowing embryologists to focus on the most skilled and technical aspects of their work.
TMRW provides a 100% digital chain of custody. This includes continuous local and remote electronic monitoring with integrated processes producing 10,000 daily digital signals which are used to constantly monitor, maintain and safeguard the integrity and security of the reproductive cells in our care.
As requested by our physician partners, the TMRW platform is designed for both in-clinic and remote storage.
The TMRW team includes many of the world’s most celebrated pioneers in clinical medicine, reproductive biology and embryology, vitri...fication, and cryogenic biobanking who have synthesized their collective knowledge, vision and experience in the development of the TMRW system.