Technology Transfer Engineer

Job Description

The successful candidate will lead the QA element of process / technological improvements and product transfers in conjunction with local Quality, Operations and company R&D personnel ensuring timely communication to all stake holders to effect successful project completion.

Roles/Responsibilities

• Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products.
  
• Quality process specifications to be compiled for on site production and purchased for resale goods.
  
• Compile and execute validation protocols for new product/processes and software.
  
• Provide QA input for URS for new technology / equipment.
  
• Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during
  
• Lead Design for Inspection activities for all NPD to ensure latest technology is available.
  
• Lead QA input in Design for Manufacture activities on site.
  
• Provide technical assistance to carry out problem analysis/complaint investigations and define through effective corrective actions.

Skills/Experience

• A degree level or similar qualification in mechanical or industrial engineering.
  
• Minimum 5 years experience in a quality role within a medical devices company.
  
• Proven ability to successfully introduce new product development in the Medical Device Industry.
  
• Proven knowledge and ability regarding product verification and process validations.
  
• Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
  
• Proven experience and training in Mechanical Engineering processes.

For more information on this role, please contact Gemma Nesdale in confidence on (021) 2300302 or email: gnesdale@brunel.ie