Quality Engineer II

TalentBoost (Quanterix) - Billerica, MA

Quanterix is a company 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. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping researchers advance the science of precision health. Simoa® is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. To continue our growth, we are hiring a Quality Engineer II located in Billerica, MA.

We are looking for an experienced and motivated candidate to join our Quality Assurance team. This individual will be responsible for supporting Product Quality needs within the Quality organization. The role will work with multiple groups within the organization to support efforts to gather, analyze, prioritize and communicate various product quality information to maximize customer satisfaction. These efforts will include addressing Six Sigma/Lean/Continuous Improvement related activities.

What You’ll Do:

  • Works with Assay Development, Engineering, Operations, Quality Control and Service groups to support gathering, analyzing and translating internal and external customer feedback (complaints, deviations, NCMR’s, etc.) to improve product quality and overall customer satisfaction
  • Support Quality review and approval of technical documentation for design and development technical and risk management documentation through applying applicable company procedures and regulatory requirements
  • Supports reporting on top product quality trends & issues
  • Supports Assay Development, Engineering, Quality Control and Service groups to prioritize and maximize the impact of product quality improvement projects
  • Supports Assay Development, Engineering, Quality Control and Service groups to identify opportunities to drive efficiency and effectiveness of product quality
  • Supports Sales, Service, Program Management and other functions to ensure product quality data is well communicated and well understood by all key stakeholders

What We’ll Expect From You:

  • Minimum of a Bachelors 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)
  • 3+ years experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline arena desired
  • Working knowledge and application of device regulations, including 21 CFR 820, ISO 9001, ISO 13485, ISO 14971
  • In-vitro diagnostic (reagents and instrumentation/software) experience desired
  • Able to work independently, with minimal daily guidance
  • Excellent cross-functional team participation skills
  • Highly organized and detail oriented
  • Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software
  • Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude is a must


Why You’ll Like Working For Us:

Our Technology: Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

Our Commitment To Employees: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free bagels every Monday morning, and free snacks and drinks every day! Quanterix hosts Virtual Bingo nights with all employees when we can see families, pets, and win amazing prizes. Unwind on Tuesdays and Thursdays with a virtual yoga session. In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Maternity & Paternity leave, Family Medical Leave, Fertility Assistance, Dependent Care, Military Leave and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance.

TalentBoost is now Ignyte AI.

This job has been posted by Ignyte AI on behalf of Quanterix. Ignyte AI is committed to the fundamental principle of equal opportunity and equal treatment for every prospective and current employee. It is the policy of Ignyte AI not to discriminate based on race, color, national or ethnic origin, ancestry, age, religion, creed, disability, sex and gender, sexual orientation, gender identity and/or expression, military or veteran status, or any other characteristic protected under applicable federal, state or local law.

Posted On: Tuesday, May 30, 2023

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