Quality Assurance Specialist

  • Job ref:


  • Location:

    Manchester, United States

  • Sector:

    Quality Engineers

  • Contact:

    Bob Giusti

  • Published:

    almost 3 years ago

  • Consultant:


Quality Assurance Specialist

Project Quality Assurance Specialist needed to work with a product development team in dynamic Medical Device Research and Development environment.

  • Integrate with Design and Development teams to be able to provide assistance and guidance on Quality System processes
  • Work with the Design and Development teams to generate compliant documentation
  • Maintain Design History File (DHF), including tracking deliverables, for one or more products throughout development
  • Work with the Project QA Manager to ensure development processes are compliant with procedures
  • Review and approve quality history records under direct supervision
  • Assist in investigation and resolution of project specific Corrective and Preventive Actions under the direction of the Project QA Manager
  • Assist Project QA Manager in facilitating project quality meetings
  • Conduct process audits against written procedure and identify process improvements under direct supervision
  • Participate in the development and/or revision of applicable standard operating procedures
  • Understand and provide guidance to development team on compliance with the FDA QSR and ISO 13485 Standards
  • Conduct internal audits of the company quality system and project-specific plans and procedures
  • Assist in FDA, customer and regulatory inspections


  • High school diploma with 5+ year's relevant quality experience. Bachelor's degree in a science or related discipline preferred.
  • QSR Part 820 and ISO 13485 experience a plus
  • Experience working with cross-functional teams