Bedford, Massachusetts, United States USD 130,000 – 160,000 / year

Werfen is hiring a Senior Software Quality Engineer

Responsibilities

  • Contributes to creating and maintaining quality documentation across all stages of the product lifecycle.
  • Guides teams on adherence to procedures, regulatory standards, and implements updates as regulations evolve.
  • Verifies that software products meet defined quality criteria and that documentation is accurate and complete before approval.
  • Collaborates with cross-functional teams involved in new product development or design modifications.
  • Examines and authorizes quality-related documents throughout product development phases.
  • Assists in internal and external audits and drives corrective actions to sustain quality management system compliance.
  • Detects gaps in regulatory compliance and initiates necessary corrective measures.
  • Engages in, and may lead, initiatives aimed at enhancing the quality management system.
  • Completes additional tasks as assigned, with reasonable accommodations available for individuals with disabilities.
Required Skills
Test Automation
About company
Werfen
Werfen is a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through its OEM business line, it researches, develops, and manufactures customized assays and biomaterials.
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Job Details
Department Quality Assurance
Category other
Posted 4 months ago