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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Design Quality Engineer - **Company:** Quanterix Corporation - **Location:** Billerica, MA, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Spreadsheets, Cyber Security, Databases, Text Processing, Verification and Validation (Software), System Testing, Iq/oq/pq, Trackwise, Industrial Software - **Published:** August 20, 2026 - **Apply:** https://jobs.localjobnetwork.com/apply/add/87364252/1 ## About the Role * 5+ years' experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline arena desired. * Minimum of a Bachelor's Degree required in related field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent), Advanced degree is a plus (M.S. in a Life Science, or equivalent). * Experience supporting regulated medical devices, diagnostics, life sciences, or related healthcare products. * Experience with instrumentation, software, reagents or a combination of these technologies is preferred., * Familiarity with one or more applicable medical device regulations and standards, such as ISO 14971, ISO 13485, EN61010, IEC 62304, IVDR and 21CFR820. * Able to work independently. * Excellent cross-functional team participation skills. * Highly organized to manage multiple projects and detail oriented. * Proficiency with standard business tools: word processing, presentations, spreadsheets, manufacturing software, database software. EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES: * Billerica, Massachusetts (Hybrid) * Travel less than 10% * Experience using eQMS tools; Mastercontrol, Arena, TrackWise, etc. ## Description Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of life and longevity. We are on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease. To make this vision a reality, we brought together the most experienced management team, renowned scientists, industry leading investors and expert advisors, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health. ROLE SUMMARY: We are looking for an experienced and motivated Senior Design Quality Engineer to join our Quality Assurance team. This role will provide Quality Engineering support transitioning our HD-X platform from Research to the Diagnostics marketplace. The Senior Design Quality Assurance Engineer, with instrumentation focus, develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet Quanterix, customer, and regulatory requirements. It serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, and corporate quality goals and priorities. WHAT YOU'LL DO: * Support the New Product Development process to ensure design projects comply with internal design control procedures. * Apply knowledge of Design Control and Quality Engineering principles to positively influence new product development efforts, including those for Voice of the Customer, establishing design inputs/outputs, Design Verification & Validation, Process Qualification & Validation, and Risk Management. * Work with Assay Development, Instrument engineering, Operations, Service and other teams as needed to support vendor qualification, software validation, instrument IQ/OQ/PQ and assay system validation. * Assess post launch purposed design changes to determine impact on risk level, verification and/or validation testing. * Maintain Risk Management Files in compliance with regulatory requirements and local procedures. * Provide support was external compliance requirements such as Safety, EMC, RoHS, China RoHS, WEEE, and Cybersecurity. * Support other quality and compliance activities as required including supporting regulatory submissions, internal audits and inspections. * Help to drive and foster a quality environment and mindset throughout the business. * Support special projects as needed. ## Related Videos - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Quantum DevOps - Enabling Industrial Engineering](https://www.wearedevelopers.com/videos/100282-quantum-devops-enabling-industrial-engineering) - [Fault Tolerance and Consistency at Scale: Harnessing the Power of Distributed SQL Databases](https://www.wearedevelopers.com/videos/1146-fault-tolerance-and-consistency-at-scale-harnessing-the-power-of-distributed-sql-databases) - [Self-service Quality: QA Without QA](https://www.wearedevelopers.com/videos/100184-self-service-quality-qa-without-qa) - [Quality Strategy with a side of Swiss Cheese](https://www.wearedevelopers.com/videos/467-quality-strategy-with-a-side-of-swiss-cheese) - [Branch your database like your code: How schema changes and pull requests go hand in hand](https://www.wearedevelopers.com/videos/350-branch-your-database-like-your-code-how-schema-changes-and-pull-requests-go-hand-in-hand) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Dev Digest 121 - AI goes offline](https://www.wearedevelopers.com/magazine/456-dev-digest-121-ai-goes-offline)