ShiraTronics Inc.

Key Requirements:

  • BS in an Engineering or Life Sciences discipline.
  • 3+ years Quality Engineering experience.
  • Knowledge of ISO 13485:2016 and 21 CFR Part 820.
  • ISO 13485:2016 Lead Auditor Certification and/or ASQ Certified Quality Engineer (CQE).

Key Responsibilities:

  • Developing inspection procedures to ensure product conforms to specifications.
  • Coordinating Receiving Inspection, Non-Conforming Material Reporting (NCMR) and Product Disposition activities.
  • Assisting with complaint investigations and associated documentation.
  • Interfacing with Regulatory Affairs to support FDA submissions.
  • Serving as an internal auditor in support of the ShiraTronics internal audit program.
  • Assisting with execution of the ShiraTronics Corrective and Preventive (CAPA) process.
  • Supporting Quality Management System (QMS) ISO 13485:2016 certification activities.
  • Providing Quality review of proposed documentation and/or product changes.