Full-Time

Quality Assurance Engineer II

Quanterix

Quanterix

201-500 employees

Quanterix offers Simoa technology, utilizing microarray printer and

Data & Analytics

Junior, Mid

Billerica, MA, USA

Requirements
  • Bachelors Degree in related field (Biomedical, Electrical, Mechanical Engineering or equivalent)
  • 3+ years experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline arena
  • 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
  • Proficiency with standard business tools
  • Strong work ethic and organizational skills
Responsibilities
  • Support product quality needs within the Quality organization
  • Gather, analyze, prioritize, and communicate various product quality information
  • Address Six Sigma/Lean/Continuous Improvement related activities
  • Support Quality review and approval of technical documentation
  • Report on top product quality trends & issues
  • Prioritize and maximize the impact of product quality improvement projects
  • Identify opportunities to drive efficiency and effectiveness of product quality
  • Ensure product quality data is well communicated and well understood by all key stakeholders

Quanterix offers Simoa technology, utilizing microarray printer and ultrasensitive immunoassay platforms based on bead and planar technologies, to enable ultra-sensitive biomarker detection for earlier disease diagnosis and precise treatment methods in various therapeutic areas, including oncology, neurology, cardiology, inflammation, and infectious disease.

Company Stage

IPO

Total Funding

$559.6M

Headquarters

Billerica, Massachusetts

Founded

2007

Growth & Insights
Headcount

6 month growth

7%

1 year growth

21%

2 year growth

-6%
INACTIVE