Quality Assurance Manager

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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 extraordinary growth, we are hiring a Quality Assurance Manager located in Billerica, MA.   

We are looking for an experienced and motivated candidate to join our Quality Assurance team. This individual will be responsible for managing a group of mid-senior level Quality Assurance Specialists who are working on product development activities, audit activities, complaint handling, deviations and out of specification documents, CAPA’s, supplier management and management review. Also responsible for reporting on trends and key Quality Assurance metrics.

What You’ll Do:

  • Support the Product Development efforts as a member of the Product Development team. Inputs to and/or approves test development, protocols, reports, inspection instructions, Design Reviews, Design History File, etc.
  • Support ISO 13485, IVDD, CLIA certification processes and compliance to FDA’s QSR by assisting with 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.
  • Participate in development of corrective action plans and oversee the corrective action and preventative action (CAPA) program.
  • 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.
  • Manage and develop QA staff members; plan and implement QA resources to support R&D, manufacturing, and marketing teams.
  • 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 required with 6+ years related QA and 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.
  • ASQ CQE and CQA preferred.
  • 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.

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.

 

Our Culture: Quanterix is committed to a Diverse and Inclusive workplace. We have a Diversity Program with Executive Sponsorship. Our core values are Accountability, Teamwork, Trust, and Transparency OR ATT2. Meet some of our team HERE. 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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