Product Quality Assurance Associate

Change Control Engineer

Ref: 93| Posted: 14th Nov 2022

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Terumo Aortic are currently recruiting for a Change Control Engineer to join our Quality department. This is an exciting role supporting key quality processes to ensure these are compliant with the required regulations. This role offers excellent career development and growth. 

The main responsibilities of the role are; 
  • Engineering team, work as a multi-skilled group to support R&D, Manufacturing and Quality projects
  • Provide consultation and support to R&D and Manufacturing in the development of change control plans
  • Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
  • Control of change control records
  • Preparation of quality system documentation
  • Maintenance and improvement of the change control process
  • Provide guidance to Associates in relation to the change control process

The successful candidate will possess; 

  • Relevant Science/Engineering Degree (equivalent experience may be considered)
  • Proven experience in Quality Management Systems in a similar role within a medical device or a similar regulated environment
  • Strong analytical and problem-solving skills
  • Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
  • Excellent facilitation, coordination, prioritization, presentation and communication skills
  • Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
  • Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department