Quanterix · 1 month ago
Senior Quality Laboratory Specialist
Bedford, MA
Full-time
Hybrid
Mid, Senior Level
$98K/yr - $120K/yr
5+ years expQuanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. The Senior Quality Lab Specialist will ensure regulatory compliance, lead audits, and drive continuous improvement of the Quality Management System.
BiotechnologyHealth CareHealth DiagnosticsLife SciencePharmaceutical
Responsibilities
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
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 existing Quality Management System
Qualification
Required
Bachelors Degree in life sciences (Medical Technology, Chemistry, Biology or biomedical engineering)
5+ years of experience in a Quality role supporting a regulated medical device, IVD, or pharmaceutical company QMS
Preferred
5 years of experience in a Quality role supporting CLIA, ISO 15189, or GCLP
Experience conducting Quality audits
Benefits
Competitive health, dental, and vision benefits for employees and their dependents
401k plan with employer match
Unlimited vacation policy to all exempt employees
Generous PTO policy for non-exempt employees
Equity
Employee stock purchase plan
Performance bonus
1:1 financial counseling/planning
Tuition Assistance
Free, state-of-the-art onsite fitness center for all employees
Free snacks and drinks every day
Company
Quanterix
Quanterix is a biotechnology company that develops ultrasensitive biomarker detection for healthcare.
201-500 employees
H1B Sponsorship
Quanterix has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (4)
2021 (6)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$533.3MKey Investors
Alzheimer's Drug Discovery FoundationT. Rowe PricebioMerieux
2022-03-29Grant
2021-02-08Post Ipo Equity· $287.5M
2020-08-06Post Ipo Equity· $97.6M
Leadership Team
Vandana Sriram
Chief Financial Officer
Darrin Crisitello
Chief Commercial Officer (CCO)
Recent News
2026-01-17
Company data provided by crunchbase