Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognosis, and precise 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, including oncology, neurology, cardiology, inflammation, and infectious disease.

ROLE SUMMARY: 

We are looking for an experienced and highly motivated Senior Quality Assurance Engineer to join our Quality Assurance team located in Billerica, MA. 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, Quality Control and Service groups to support gathering, analyzing, and translating internal and external customer feedback (complaints, field service reports, deviations, NCMR’s, etc.) to improve product quality and overall customer satisfaction
• Apply knowledge of Design Control principles and quality engineering to positively influence new product development and sustaining efforts, including those for design verification, validation, and specification development
• Provides cross-functional direction to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards
• Optimize and implement manufacturing processes, procedures in support of process flow and value stream mapping improvements for existing products
• Contributes to internal, and supplier audits by consultancy or participation
• Contributes to Defect-, CAPA-, and Change Management activities
• Supports communication to customers as required based on product issues in the field
• Supports Assay Development, Engineering, Quality Control and Service groups to prioritize and maximize the impact of product quality improvement projects
• Provide on the floor QA support to manufacturing, QC, development and other areas as needed
• Supports Sales, Service, Program Management, and other functions to ensure product quality data is well communicated and well understood by all key stakeholders

BASIC QUALIFICATIONS: 

• Bachelor’s degree in biomedical, electrical, or mechanical engineering
• 5-8 years’ experience in a Quality function within the Medical Device, Biotechnology, Life Sciences industry

PREFERRED QUALIFICATIONS: 

• M.S. in Life Sciences
• In-vitro diagnostic manufacturing environment (reagents and instrumentation/software) experience desired as is awareness of QSR and ISO regulatory requirements
• Floor support experience 

EXPECTATIONS, SKILLS & ABILITIES: 

• 100% on-site role
• 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
• Provide on the floor QA support to manufacturing, QC, development and other areas as needed
• Strong work ethic and organizational skills to manage multiple projects under tight deadlines with a collaborative attitude

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: At Quanterix, we take pride in our employees’ incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible to be awarded Equity, and we have an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day! 

DIVERSE & INCLUSIVE WORKPLACE: Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. 

Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. 

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