Our Quality Systems Manager is responsible for contributing to the development and implementation of the 23andMe Quality system to ensure compliance with requirements and standards set forth by regulatory and accrediting agencies. A qualified candidate must establish and develop effective partnerships with internal resources to facilitate the timely identification and resolution of compliance / quality matters. Come join us!
Responsibilities include but are not necessarily limited to:
Contribute to the development and maintenance of the 23andMe Quality System.
Develop and maintain the Internal Quality Audit system; perform periodic internal audits of the quality management system to ensure compliance to written procedures and regulatory requirements.
Contribute to the definition of requirements for 23andMe approved suppliers for materials, equipment and services. Conduct supplier assessment audits and surveys.
Generate audit/assessment reports/trending analyses, and proposals for resolution.
Manage Corrective and Preventive Action (CAPA) system.
Coordinate MDR investigations.
Assist in the acquisition and generation of documentation for submission(s) to regulatory agencies.
Provide support to quality management in the preparation for, conduct of, and follow-up activities associated with site visits from clients and regulatory/ accrediting agencies.
Participate in organizational project teams providing both quality and regulatory input to the product development process.
Contribute to the development of product requirements and specifications.
Build and manage the Document Control system to assure compliance to in-regulations and standards such as CLIA, FDA and other applicable agencies. Duties include (but are not limited to):
Maintain close integration with IT and all internal users.
Function as System Administrator (e.g. with an Electronic Document Management System).
Day to day internal customer support, including training.
Document change management requests.
Participate in pre-existing QA reviews within functional groups (e.g. Customer Service, Curation) and incorporate these processes into a corporate level reporting system as part of the Management Review requirement of 21CFR820.
Work Environment: Occasional travel may be required to fulfill audit and vendor management functions. Adherence to the corporate policies, rules, and regulations in all areas is required.
Bachelor of Science degree in scientific field preferred with a minimum of 5-7 years of related experience.
Knowledge and understanding of both CLIA and in vitro diagnostics (IVD) compliance and regulatory requirements a must.
Knowledge/ Experience working in a FDA/QSR regulated environment pertaining to IVD products strongly preferred.
Ability to communicate effectively across all levels of the organization.
Computer skills competency including Excel, Word and PowerPoint programs required.
Combining web development, computer science, genetics, and informatics, 23andMe is at the forefront of a new era in personal genetics. This is your opportunity to join a talented, ambitious team that is creating truly novel technologies and products that will change the way people see themselves and the world. Come join us!
23andMe - 20 months ago