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.
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We are looking for an experienced and highly motivated Quality Assurance Engineer II in Billerica, MA 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 Manufacturing groups to prioritize and maximize the impact of product quality improvement projects
- Supports Assay Development, Engineering, Quality Control and Manufacturing 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, Electrical, Mechanical Engineering or equivalent), Advanced degree is a plus (M.S. in a Life Science, Engineering 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
- 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: 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 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!
Quanterix is committed to a Diverse and Inclusive workplace. 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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