Jobs - QA and Regulatory Director, Medical Devices

Hexoskin is looking for a QA Director to join its development team.

Work environment

The QA Director is in charge of the Hexoskin Quality System, its implementation, control and maintenance. She/he works closely with the R&D team and interacts with people throughout the company, from software to hardware to textile. We are results-oriented and passionate about delivering leading innovative products to a large international community.

Responsibilities

  • Lead the Design Control Process as per ISO13485, FDA, CE, military, space, and other international regulatory requirements.
  • Write Product Maintenance release plans.
  • Implement necessary development and deployment processes.
  • Develop and manage quality assurance metrics for performance improvement.
  • Assure the viability, applicability and effectiveness of QA tools and reporting.
  • Participate in Operational Review meetings with upper management & Finance.
  • Support external audits of the design control and New Product Development systems.
  • Review and approve claim support data and V&V protocols/reports.
  • Develop verification and validation (V&V) strategies to support Hexoskin Quality System.
  • Interact with regulatory agencies (FDA, Health Canada) on behalf of the company.

    Competencies

    • Strong analytical skills and experience with implementation and administration of Software Quality Assurance metrics.
    • Solid experience in product development with FDA, FAA, Military or Space Quality Systems.
    • Experience with Agile development and design a plus.
    • Excellent communication skills both written and oral.
    • Rigorous work ethics.
    • Strong understanding of software testing methods, principles, and tools.
    • Experience with writing and reviewing test plans, test cases, and bug reports.

    What we offer

    • Health-related projects (sports, health research, sleep medicine, space missions, etc.)
    • Fast growing startup, recognized as an industry leader in wearable health tech.
    • Lots of opportunities to innovate and take initiatives.
    • You get to work with the latest wearable health devices.
    • Health benefits.

    Hexoskin

    Hexoskin is a health technology company founded in 2006. Our mission is to record and organize personal health information and make it accessible and useful. We’re a small team of 25 carefully selected people who work in collaboration with designers, manufacturers, health organizations and partners in more than 30 countries. We’re proud to count among our clients elite athletes, space agencies, government organizations and more.

    Our offices are located at 5800 St-Denis, just in front of metro Rosemont, a 5 minute walk from the Plateau and Mile-End, a few steps from the bike road on Des Carrières.

    Please send you resume and relevant projects to: jobs@hexoskin.com
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