Sanvita Medical, an exciting new medical device company in diabetes healthcare operating within one of Nova Biomedical’s facilities, is hiring a Quality Assurance Engineer. Reporting to the Quality System Manager, in this newly created role, you will focus on assuring company compliance to FDA QSR, ISO 13485, and ISO14971, as well as additional regulatory requirements with a principal focus on suppliers and manufacturing. Supporting the pending commercialization of a new and innovative medical device, your responsibilities will include development of metrics for all areas of the supplier, incoming (MRB and NCMRs), and manufacturing quality and report metric results at Product Reviews.
As a quality professional in the medical device industry in the Boston area, we know that you have a vast amount of opportunities. What makes this one unique? Our company is transitioning from R&D to building and launching a product. This is a mid-level career opportunity for a quality engineer to partner with manufacturing operations, take ownership of quality projects, and learn and grow with our company.
To qualify for this position, you need a Bachelor’s degree in a technical or a scientific discipline; Master’s degree is a plus. 3+ years of relevant experience in a medical device company, could include roles in quality assurance, quality control, or manufacturing engineering. Cleanroom experience is a plus.
Nova Biomedical develops, manufactures, and sells advanced technology blood testing analyzers. We employ over 1,200 people, with sales and service subsidiaries in eight countries and distributors in more than 91 additional countries. Nova has manufacturing facilities in Waltham and Billerica, Massachusetts; and Taipei, Taiwan. Nova is one of the 25 largest in vitro diagnostic companies in the world and the largest privately owned in vitro diagnostic company in the United States.