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 Assurance Manager located in Billerica, MA. This position will be part of our Quality Assurance team. The Quality Assurance Manager will be responsible for maintaining and coordinating review and processing of internal documents in the document control system. In addition, they will be responsible for providing numbers for Quality Assurance documents, supporting exam development for training, and regularly reporting on training progress on new and revised documents. This individual will also be responsible for assisting in the writing and editing of technical documents for our growing product portfolio. The individual will also be the primary contact with users of the document management system.

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
• 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
• Design, compile, analyze, trends and issue QA performance metrics reports
• Coordinate/track/drive closure of audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner
• Write and implement standard operating procedures and work instructions for QA actions
• Coordinate quality training and help foster a quality-oriented culture

What We’ll Expect From You:

• BS/BA degree
• 7+ years related ISO 13485 Quality Assurance or Quality Systems experience
• 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: 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: Monday, May 22, 2023