Sr. Quality Lab Specialist

Senior Quality Lab Specialist

Bedford, MA

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.

We are looking for a skilled and experienced Senior Quality Lab Specialist to join our Quality team in Bedford, MA. The Senior Quality Lab Specialist will ensure regulatory compliance, lead audits, and drive continuous improvement of our Quality Management System. This position will be onsite for training and has the potential to work a hybrid schedule.

• Establish and maintain a culture of trust and compliance with established Quality standards.
• Participate on cross‑functional project teams to provide guidance to meet the Accelerator QMS.
• Ensure Accelerator Laboratory Service’s compliance with CLIA regulations, ISO 15189, and GCLP guidelines through assessment of established Quality Systems and education and training of laboratory staff in Quality Principles.
• Oversee internal sample tracer audits and other audits as needed.
• Provide QA review support of SOPs, validation protocols and reports, deviations, and CAPAs.
• Prepare and present quality audit reports for management.
• Assist in administering an internal proficiency testing program.
• Lead efforts to continuously improve the existing Quality Management System.

• Bachelor’s Degree in life sciences (Medical Technology, Chemistry, Biology or biomedical engineering).
• 7+ years of experience in a Quality role supporting a regulated medical device, IVD, or pharmaceutical company QMS.

• 5 years of experience in a Quality role supporting CLIA, ISO 15189, or GCLP.
• Experience conducting Quality audits.

Quanterix is committed to a diverse and inclusive workplace. We strive to recruit candidates who will contribute to our values.

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.