Supplier Quality Engineer

Supplier Quality Engineer

Ref: 207| Posted: 15th Jan 2024

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Terumo Aortic are currently looking to recruit a supplier quality engineer to join our Quality Assurance Engineering team. This is a fantastic opportunity to join the business during an exciting time of growth and investment.

The main responsibilities of the role include;

  • Provide Quality Engineering support to ensure robust, risk-based processes for supplier management to control & drive supplier continuous improvement initiatives
  • Ensure that all related processes and procedures meet the requirements of all applicable regulatory standards; EU Medical Device Regulations; ISO 13485; FDA 21 CFR 820, Japan MHLW Ordinance 169, associated Canadian, Australian, Brazilian and Taiwanese regulations and others as appropriate
  • Promote a culture of high performance, continuous improvement and regulatory compliance with a commitment to quality
  • In conjunction with Procurement, support & maintain all aspects of the supplier management programme
  • Maintain a consolidated list of approved suppliers
  • Develop & maintain - Quality Agreements for all key suppliers, ensuring all - statutory requirements are fully defined
  • Develop & maintain supplier rating process & balanced scorecards for all key material, component & service suppliers
  • Develop & maintain a Supplier Corrective Action process to facilitate continuous improvement within the supply base
  • Maintain supplier audit schedule
  • In conjunction with relevant Subject Matter Experts & Procurement, work to resolve NCRs of supplier origin via the SCAR process
  • In conjunction with R&D & Procurement manage a stream-lined process for control of developmental suppliers
  • Work collaboratively with other functional areas to effectively investigate & resolve supplier issues, deploying appropriate tools to assist root cause analysis & risk assessment
  • Provide trending data & reports upon request to senior management, functional managers, regulatory authorities & customers
  • In conjunction with R&D & Operational Quality or Incoming Goods, ensure effective incoming specifications for raw materials & assemblies are in place
  • In conjunction with Quality Engineering – ensure that critical direct (material) suppliers processes have been appropriately validated
  • Work  towards meeting departmental & facility objectives
  • Support facility Internal Audit programme
  • Development of cross-functional & collaborative relationships within the facility
  • Development of effective internal & external customer relationships to ensure quality & regulatory compliance for the business


The successful candidate will possess;

  • Relevant Science / Engineering Degree
  • Lead Assessor qualified
  • Proven experience in Quality Management Systems in a similar role within a medical device environment
  • Experience in a global company within a regulated industry, preferably medical device, or pharmaceutical manufacturing
  • Experience of FDA regulations
  • Thorough knowledge of regulatory standards, Quality Management Systems & global regulations for medical devices
  • Strong analytical & problem-solving skills
  • Excellent facilitation, coordination, prioritisation, presentation & communication skills
  • Proven ability to manage & prioritise workload, meet deadlines & work in a pressurised environment
  • Competence in the use of IT technology, such as Microsoft Office applications, & the ability to learn other IT systems used in the QA department