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Quality Assurance Manager

  • Job type: Permanent
  • Location: Austin
  • Salary: $90000 - $105000 per annum
  • Job reference: EPM
  • Sector: EPM Scientific, Quality
  • Date posted: 27/02/2018

Job description

Our client, an established Medical Device company based in the Austin area, is currently looking to bring on board a Quality Assurance Manager.

  • Responsible for maintenance and management of the Site Quality System under ISO 13485, CMDR, IVDD and other global standards.
  • Maintenance and management of document control process, failure investigations, corrective and preventative action plans, customer support programs, supplier quality management system, internal & external audit programs, and product release activities.
  • Conduct internal audits for compliance to established Quality Manual and applicable international and regulatory standards
  • Participate in engineering change reviews
  • Participate in validations
  • Responsibilities for implementation, maintenance and management of LMA Quality Systems according to US FDA, ISO 13485 (under CMDR and IVDD)

  • BA or BS in relevant field
  • Experience in medical device manufacturing environment
  • Certification in quality such as CQA, CQM, CQE
  • Knowledge of current industry practices under ISO 13485, CMDR and IVDD Quality System preferred

If interested, get in touch with
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