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Design Control Specialist

2 weeks ago

Dublin, Dublin City, Ireland PQE Group Full time

PQE Group is a world leader in the Pharmaceutical and Medical Device industries.

We are seeking a Design Control Specialist to support our projects in Dublin, Ireland.

The successful candidate will be responsible for:

  • Providing technical support for the transfer of manufacturing of Devices and Combination Products from R&D to commercial manufacturing sites as per the design control process in compliance with ISO 13485 and 21 CFR 820.
  • Delivery of the Technical Transfer Plan and Report outlining the transfer of all required deliverables including equipment requirements and manufacturing and testing specifications.
  • Acting as an interface between R&D and the commercial manufacturing sites during device/combination product development and providing support for the troubleshooting of all device-related issues/investigations.
  • Responsible for driving knowledge transfer and training on relevant technical transfer activities to the commercial site.
  • Manage, review, and approve change controls issued from the commercial site or from R&D which are deemed to impact the device/combination product.
  • Developing manufacturing process understanding by use of tools such as Cause and Effect, providing linkage to all aspects of manufacturing and utilized to identify any potential failures.
  • Provide technical support and act as a technical SME on site as required at suppliers or manufacturing sites for device-related complaints, support device-related investigations to root cause and the establishment of appropriate corrective actions.
  • Engage with Device Program Teams in support of Technical Reviews, Technology Transfers and Design Transfers across the portfolio.
  • Provide input into Routine Program Review process.