Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

Billerica, 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. 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 Quality Assurance team. This individual will be knowledgeable in medical devices adhering to ISO 13485 and ISO 9001 requirements. This individual will support Quality Assurance in the Product Quality Department by acting as a coach to the junior Batch Release staff. Will be responsible for executing batch record review, production label approvals, and quality event support.

• 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.

• Bachelor's degree in science, Medical Technology, English, or Technical Communications preferred.
• 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.

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 lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.

Akoya Biosciences, a Quanterix company, is The Spatial Biology Company-bringing tissue context to life through high-resolution, single-cell imaging. Akoya's spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including Pheno Cycler, Pheno Imager Fusion and HT, and Pheno Code Panels.

As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.

At Quanterix, our values are based on:
Team, Innovation, Customer and Owner.

Team:
Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty…