If you have an unrelenting eye for detail, a commitment to continuous improvement, and a passion for helping people, you may be the Quality Specialist that we are seeking. Our Quality Specialist is responsible for maintaining the Quality Management System in accordance with FDA Quality Systems Regulations, ISO 13485 and other applicable country-specific regulations.
As a Quality Specialist, you will work across teams in the organization to support the manufacture, testing, and release of products using controlled processes to assure that they meet all customer and regulatory requirements. In addition, our Quality Specialist is a key member of the quality improvement team, monitoring products and processes for regulatory compliance, continuous improvement and process efficiency.
PRIMARY (Essential) FUNCTIONS:
Coordinate regular reviews and releases of product batches to ensure compliance to customer and regulatory requirements, including generating Certificates of Compliance when applicable.
Coordinate the document control workflow for product and process change management.
Support our complaint handling program by performing entry and analysis of complaint and repair data and coordinating with the Customer Service team to ensure cases are closed in a timely manner.
Coordinate the supplier evaluation and approval process through interfacing with new suppliers to gather evaluation materials and Coordinate internal review and approval of evaluation materials.
Support our internal audit program.
Bachelor’s Degree in a scientific or engineering field or 5+ years of experience in medical device or pharmaceutical Quality Assurance.
2 years of relevant industry experience.
Working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, etc.)
About Lifeline Scientific, Inc.
Lifeline Scientific, Inc. is dedicated to developing and marketing advanced medical products and services designed to improve patient outcomes in transplantation. Our aim is to help provide more and better quality organs, tissues and cells, in support of transplant professionals worldwide and the life-saving services they provide. We are the world’s leading provider of organ preservation products and services. At the heart of our business is a commitment to honor a donor’s precious gift of life. We do this by developing technologies to help transform transplant patient outcomes and lower overall cost of care. Through delivering truly innovative, high quality, medical devices and support systems, we are at the forefront of revolutionizing donor organ preservation from a simple box of ice. As dedicated toolmakers to the transplant community, we are building upon our expertise and knowledge to help improve the quality and availability of donor organs and thereby, the future of organ transplantation.