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Director / Sr. Director, Quality Assurance (Medical Device/IVD)

Job Summary:

The Senior Director/Director, Quality Assurance, reporting to the Vice President of Quality Assurance and Regulatory Affairs, in conjunction with executive management and Regulatory Affairs, develops strategic and tactical plans to ensure compliance with national and international quality management system requirements. This individual has overall responsibility for maintenance and continuous monitoring and improvement of the Company's Quality Management System, in conformance with ISO-13485, FDA's QSR/GMP requirements, and any other applicable regional in vitro diagnostic regulations.

Essential Duties:

  • Lead and develop the Quality Assurance team which comprises:  Quality Assurance, Change Control and Quality Engineering.
  • Develop and Implement a Quality Strategic Plan for supporting Life Sciences, RUO, and Diagnostic medical devices.
  • Maintain ISO-13485 registration.
  • Ensure on-going compliance with FDA's QSR/GMP requirements and any other applicable regional in vitro diagnostic regulations.
  • Serve as the primary point of contact with the Company's notified body/external auditor
  • Drive continuous monitoring and process improvements.
  • Partner with cross-functional leadership to ensure all aspects of Product Development and Delivery are performed in conformance to the quality management system and regulatory requirements.
  • Improve customer satisfaction through Quality initiatives and process improvement.



  • Undergraduate or advanced degree (B.S., M.S., or Ph.D.) in a Life Science.
  • A minimum of ten (10) years of experience implementing and/or maintaining quality management systems in an FDA GMP or ISO-13485 regulated industry setting.
  • At least seven (7) years of management experience in a medical device company (class II or class III) with both domestic and international products.
  • In-depth knowledge of and experience with ISO-13485, ISO 14971, GMP/GLP, QSR, 21 CFR 820.30, and other medical device (IVD) regulations.
  • Experience building and leading high performing teams, including direct-report managers.
  • Proven ability to lead cross-functional teams in problem-solving and continuous process improvement.
  • Experience with medical device (IVD) software, hardware and reagent development.


  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.


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