Job Description

Key Deliverables:

  • Provide quality oversight across design, validation, and lifecycle of combination products
  • Support regulatory submissions, audits, and RTQ responses
  • Ensure compliance with global standards including ISO 13485 and 21 CFR
  • Lead quality process improvements for device, labeling, and packaging

Role Responsibilities:

  • Act as single point of quality contact for final product activities
  • Review risk management, HFE documentation, and design controls
  • Train teams on quality and regulatory requirements for combination products
  • Manage complaint investigations and site transfer quality activities


Skills Required
quality engineering, Risk Management, design control, Iso 13485

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