Quality Systems Engineer

Quality Systems Engineer (QMS)

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades.

In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue‑advancing precision medicine from discovery to diagnostics.

We are looking for an experienced and motivated candidate to join our QA/QMS team. This individual will be responsible for supporting the various Quality Management System (QMS) processes across the organization. The role will work with multiple groups within the organization to support efforts to gather, process, analyze, prioritize and communicate various information to maximize process efficiency and customer satisfaction. These efforts will include addressing Six Sigma/Lean/Continuous Improvement related activities.

• Support development and maintenance of Quality Management System planning, policies, processes, procedures, and controls ensuring Performance and Quality of Quanterix products and services conform to ISO 9001, ISO 13485, IVDR, 21
  
  CFR
  820 and other applicable regulatory agency guidelines
• Support various QMS activities for the development, implementation, monitoring, and improvement of Quanterix processes maximizing operational efficiency and customer satisfaction
• Support the processes for qualifying new suppliers, analyze and improve supplier performance, implement corrective actions or quality improvement plans, and maintain the Approved Supplier List
• Work closely with the Procurement team as needed to select, evaluate, qualify, and develop suppliers by performing initial and periodic follow-up assessments and audits
• Support Electronic Document Management System (eDMS) administration, including controlled document processing and revisions, revision control, training and exam creation/updates, maintenance of training job codes and assignments, publication of training materials, and continuous improvement of processes
• Support audits of systems, processes, and products to ensure compliance with regulations and the QMS including third party and customer audits, ensuring timely resolution of observations and nonconformities
• Support the feedback/complaint handling process through maintenance of complaint cases, processes, and procedures, including requirements for test plans, and investigation protocols as needed
• Analyze trends and develop performance metrics reports to track/drive closure of QMS Audits, CAPAs, Deviations, etc. to ensure closure and implementation in a timely manner

• BS/BA degree in Biotechnology, Life Science, Engineering, or equivalent
• 2+ years related ISO 9001 and/or ISO
  13485 Quality Management Systems experience
• Strong understanding of QSR and ISO regulatory requirements

• Advanced degree (M.S. in Life Sciences, or equivalent)
• Professional certification (i.e., Six Sigma, ASQ certifications, PMP)
• In‑vitro diagnostic (reagents and instrumentation/software) experience

• Location:
  
  Billerica, MA
• Highly organized and detail oriented
• Strong work ethics and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must

From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far…