Senior Quality Systems Engineer

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, Simoa, 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 Senior Quality Systems Engineer (QMS) to join our Quality Assurance team. This individual will be responsible for supporting Product Quality needs within the Quality organization. The role will work with multiple groups within the organization to support efforts to gather, analyze, prioritize and communicate various product quality information to maximize customer satisfaction. These efforts will include addressing Six Sigma/Lean/Continuous Improvement related activities.

What You’ll Do:

• Support development and maintenance of Quality Management System planning, policies, processes, procedures, and controls ensuring that performance and quality of Quanterix products and services conform to ISO 9001, ISO 13485 and other applicable regulatory agency guidelines to ensure customer satisfaction
• Support ISO 9001, ISO 13485, IVDR, 21CFR820 and other activities for the development, implementation, monitoring, and improvement of Quanterix quality systems
• Support audits of systems, processes, and products to ensure compliance with regulations and the Quality System including third party and customer audits
• Support the feedback/complaint handling process through maintenance of complaint handling QMS requirements, processes, and procedures, including requirements for test plans, and investigation protocols as applicable
• Analyze, trends and develop QA performance metrics reports
• Coordinate/track/drive closure of QMS audit report responses, CAPAs, deviations, etc. to ensure closure and implementation in a timely manner
• Support the Internal Audit Program by participating in internal audits, and supporting timely resolution of observations and nonconformities
• Write and implement standard operating procedures and work instructions for QA functions
• Develop QMS training and help foster a quality-oriented culture

What We’ll Expect From You: 

• BS/BA degree in Biotechnology, Life Science, Engineering, or equivalent minimally, advanced degree is a plus (M.S. in a Life Science, or equivalent)
• Professional certification is desired (i.e., Six Sigma, ASQ certifications, PMP)
• 5+ years related ISO 13485 Quality Assurance or Quality Systems experience
• In-vitro diagnostic (reagents and instrumentation/software) experience preferred
• Strong understanding of QSR and ISO regulatory requirements is required
• Strong understanding and experience with Design Control requirements is required
• Able to lead cross-functional teams and to work independently, without instruction
• Highly organized and detail oriented
• Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must.

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 visit https://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-JV1 #LI-Onsite