In this role as a Quality Specialist/Quality Inspector, you will be an integral member of the quality assurance team whose primary role is to ensure that quality system requirements in relation to cGMP are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidances as applicable.
The ideal candidate possesses a passion for quality, strong organizational skills, and an emphasis on attention to detail. In this role, you will play a key role in driving quality improvement projects and in ensuring consistent quality in our products and services.
Responsible for receiving and inspection of raw materials/components
Responsible for inspection of contracted kit packers
Responsible for inspection of in-process kit assembly
Responsible for final kit product release
Responsible for in-process inspection of fulfillment of orders
Identify compliance gaps and develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
Identify nonconformance trends, develop, and administer technical investigation and corrective action programs to resolve recurring internal and external opportunities to improve overall quality performances
Assist in the administration the eQMS (Electronic Quality Management System)
Provide support to RA/QA Leadership in the preparation for, conduct of, and follow-up activities associated with site visits from regulatory/ accrediting agencies
Participate in organizational project teams providing quality input to the product development process
Everly Health is the leading digital health company at the forefront of the $300 billion dollar virtual diagnostics-driven care industry. Our mission is to improve the lives of millions with a fully integrated digital care platform for consumers and businesses. We continue to innovate in the space by delivering more care to more people on a seamless diagnostics-driven platform.
Everlywell, the consumer-initiated at-home laboratory testing brand within Everly Health, has helped over 1 million people manage their health and wellness with easy at-home tests, physician-reviewed results and actionable intelligence delivered digitally in days. You know your body best, and we believe information about the way your body works should be fully visible and available to you however and whenever you need it.