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 Director of Quality Assurance in to join our growing organization. This position will lead our Quality Assurance team including Quality Systems, Quality Release and Quality Engineering to drive compliance and continuous improvement initiatives. The role provides Quality leadership and support within the organization for key strategic initiatives and directives to improve overall company performance and growth.
What You'll Do:
- Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established ISO 13485 standards and regulatory agency guidelines to ensure continued customer satisfaction
- Leads ISO 13485, IVDR, 21CFR820 activities by leading the development, implementation, monitoring, and improvement of Quanterix quality systems
- Manage/administer audits of systems, processes, and products to ensure compliance with regulations and the Quality System. Participates in and/or hosts third party audits
- Analyze internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, corporate quality standards, and Divisional and Facility quality standards
- Monitor the uniformity of the complaint handling process through maintenance of complaint handling requirements, processes, and procedures, including requirements for test plans, and investigation protocols as applicable
- Make decisions which effect product quality, regulatory compliance and the quality of product and process
- Design, compile, analyze, trends and issue QA performance metrics reports
- Coordinate quality training and help foster a quality-oriented culture
What We'll Expect From You:
- BS/BA degree, preferably in engineering, life science or technical discipline
- 10+ years related ISO 13485 Quality Assurance or Quality Systems experience
- 4+ years managing teams
- In-vitro diagnostic (reagents and instrumentation/software) experience preferred
- Strong understanding of QSR and ISO regulatory requirements is required
- Strong understanding and experience with Design Control requirements is required
- Able to lead a group and work independently, without instruction
- Excellent cross-functional team participation skills
- Highly organized and detail oriented
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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