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 Program Manager located in Billerica, MA.  

We are looking for an experienced and motivated candidate to join our Quality team. This individual will manage the QMS initiatives to support cross-functional development and commercialization of immunoassay products and processes. The position will be responsible for establishing scope, schedule, and resources for Quality programs.

What You’ll Do:

• Program leader accountable for overall program outcome; maintaining and expanding ISO 9001 & ISO 13485 QMS initiatives Program responsibilities may extend to leadership of other critical product related initiatives based on portfolio priorities and needs (e.g. process improvement programs)
• Program Core Team Leader and primary liaison to the Program Governance team
• Lead Core Team to ensure tight coordination of cross-functional deliverables and providing guidance on conformance to established Quality process improvements and ensuring successful execution of the program. Hold team members accountable for areas of responsibility to the program team and ensure support and focus on objectives
• Drive concise and clear program updates to Governance Team ensuring delivery of accurate and timely updates, and appropriate escalation and remediation of risks
• Define and document program scope, constraints and assumptions in detailed integrated program/project plans including schedule and resource needs in accordance with the strategic goals and priorities of the organization
• Establish and maintain a program risk registry and drive execution against risk mitigation plans as required to achieve program objectives
• Proactively implement and manage changes to the integrated program/project plans to ensure goals are achieved including customer satisfaction, safety, and quality, in a manner that is consistent with Quanterix company values
• Ensure program execution to appropriate quality standards of practice consistent with our Quality roadmap and Quality Management System
• Program Manager responsibilities extend to successfully managing and leading multiple high visibility, time sensitive and complex programs in parallel

What We’ll Expect From You: 

• Minimum of a Bachelors Degree required in a technical field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent), Advanced degree is a plus in Business or equivalent
• 3+ years experience of Project Management
• Working knowledge of device regulations, including 21 CFR 820, ISO 9001, ISO 13485, ISO 14971
• Experience with electronic document management systems and/or risk management software
• Experience in leading cross-disciplinary product development teams: R&D, Marketing, Quality, Field Service, Operations, etc.
• In-vitro diagnostic (reagents and instrumentation/software) experience desired
• Able to work independently, with minimal daily guidance
• 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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