Quanterix · 1 month ago
Senior Quality Assurance Specialist
Billerica, MA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $110K/yr
3+ years expQuanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. The Senior Quality Assurance Specialist will support Quality Assurance in the Product Quality Department, acting as a coach to junior staff and overseeing batch record reviews and quality event support.
BiotechnologyHealth CareHealth DiagnosticsLife SciencePharmaceutical
Responsibilities
Act as a coach and mentor to junior Batch Release staff
Responsible for review and approval of executed batch records for kit components and final kit assemblies. Identifying documents for corrections and coordinating with Manufacturing teams and Quality Control to update records & track corrections
Administer Quality Events Process. Support investigations, closures, and collect metrics for reporting
Identify and drive process improvements with the Batch Release processes
Posting assay documentation on the website (if required)
Issuance and approval of lot numbers
Support the Label request process
Coordinate onsite and offsite storage of quality records
Assist Incoming Quality Control needs
Qualification
Required
Knowledgeable in medical devices adhering to ISO 13485 and ISO 9001 requirements
3 years of Quality Assurance and/or batch record review experience
Demonstrate excellent verbal and written communication
Must be organized and have the ability to multitask
Solid work ethic and excellent attention to detail
Demonstrate strength working independently
Teamwork and the ability to work effectively across functional teams ensuring requirements are met
Skilled in organization, decision-making, and building strong business relationships
Preferred
Bachelor's degree in science, Medical Technology, English, or Technical Communications
Benefits
401k plan with employer match
Competitive health, dental, and vision benefits for employees and their dependents
Unlimited vacation policy to all exempt employees
Generous PTO policy for non-exempt employees
Eligible for 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
2026-01-09
BioWorld Financial Watch
2025-12-24
Company data provided by crunchbase