Director of Quality Assurance
Confirmed live in the last 24 hours
Quanterix
Locations
Billerica, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Quality Assurance (QA)
CategoriesNew
QA & Testing
Requirements
  • 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
Responsibilities
  • 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
Desired Qualifications
  • In-vitro diagnostic (reagents and instrumentation/software) experience
  • Experience with ISO 13485, IVDR, 21CFR820
  • Experience with Design Control requirements