Quality Assurance Specialist II

Quanterix
tuition assistance, 401(k)
United States, Massachusetts, Billerica
Sep 28, 2024
Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company's ultra-sensitive detection solution, Ssimoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix' technology is designed to enable much earlier disease detection, better prognosis and precise treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. We are looking for an experienced and highly motivated Quality Assurance Specialist to join our Accelerator Laboratory located in Billerica, MA. The Quanterix Accelerator laboratory provides contract research and clinical testing supporting cutting edge research and clinical care. The Quality Specialist will be responsible for quality review of documents for IVD products and compliance with the QMS. This role will support vendor qualification, audits, complaints, and investigations within the Quanterix Accelerator laboratory. What You'll Do: Responsible for establishing and maintaining a culture of trust and compliance with established Quality standards Participation on cross functional project teams to provide guidance to meet the Accelerator QMS. Ensure Accelerator Laboratory Service's compliance with CLIA regulations, ISO15189, and GCLP guidelines through the assessment of established Quality Systems and education and training of laboratory staff in Quality Principles Understanding of the IVD Development process and supporting standards, e.g. 21CFR820 ISO 13485, ISO 14971, cGXP guidelines Oversee Internal Sample Tracer audits and other audits as needed Provide Quality review of SOPs, validation protocols and reports, deviations, and CAPAs Assist n administering an internal proficiency testing program Play a lead role in design history and manufacturing audits Lead efforts to continuously improve existing Quality Management System Provide QA support of quality events, including deviations, Change Control and CAPAs What We'll Expect From You: Basic Qualifications: Bachelors Degree in life sciences (Medical Technology, Chemistry, Biology or biomedical engineering) 2+ years of experience in a Quality role supporting a regulated medical device, IVD, or a Pharmaceutical company Preferred Qualifications: 1 year of experience with vendor qualification 3 years of experience in a Quality role supporting CLIA, ISO 15189, or GCLP In-vitro diagnostic (reagents and instrumentation/software) Why You'll Like Working For Us: Our Technology:Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visithttps://www.quanterix.com. Our Commitment to Employees:At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day! Quanterix is committed to a Diverse and Inclusive workplace. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #LI-Hybrid #LI-JW1