3 remote jobs

Sepset Biosciences Inc. seeks applications for an experienced quality assurance (QA) and regulatory affairs manager or consultant to help with the development and regulatory approval of Sepset’s medical diagnostic test for sepsis. The QA manager will report to the CSO and work closely with senior management and company employees to implement and maintain an eQMS system as well as ensure regulatory compliance. The individual will also make sure that company leadership is engaged in quality management practices and training to ensure that company objectives regarding quality and risk management are successfully met. Qualifications and Experience MSc or PhD in biomedical engineering or biomedical science (BSc with extensive medical device development and quality management experience may also be considered). QA or regulatory affairs training an asset. At least 4 years experience working in the medical device field. Knowledge of medical diagnostic test technology,...

Job Summary The Quality Assurance (QA) Manager is responsible for the daily execution of the Quality Management System (QMS). The Manager works closely with the CMSO, CTO, COO, Chief Legal Officer and Chief Success Officer to execute on quality objectives. Works closely with quality and regulatory consultants but remains a good steward of limited financial resources. Interfaces with Contract Manufacturer quality, manages/triages installer and customer feedback, executes supplier quality audits, and manages related quality engineers. Ensures that the leadership team remains informed and educated on quality and compliance concerns and responds to all concerns with independence and thorough action to assure the success of the company. Responsibilities, Role and Function The QA Manager is responsible for the following: Daily execution of the QMS Collaborate with internal and external Engineering teams to ensure QMS processes are followed throughout the product...

We detect cancer and even precancerous tissue! 20+ clinical trials in 7 countries with 10,000+ patients Detection while still localized vs already spread has a huge impact on 5-year survival Breast 99% vs 30% Prostate 99% vs 32% Uterine 95% vs 18% Colon 91% vs 15% Lung 61% vs 7% Out test is safe, highly accurate, affordable, easy to conduct in office in 15 minutes!  Our test will have a huge impact on cancer mortality! We need an experienced CEO to start saving lives with this remarkable technology