Permanent
Supplier Quality Engineer
Inchinnan

Senior Supplier Quality Engineer

Ref: 78| Posted: 28th Nov 2022

Terumo Aortic have an excellent opportunity to join us a Senior Supplier Quality Engineer, this is an excellent role that will support processes to ensure robust, risk-based processes for supplier management to control & drive supplier continuous improvement initiatives.

The main responsibilities of the role are;

  • Directly support the Engineering Leader -Supplier Quality  and take charge of key SQE deliverables with minimal supervision.
  • Lead Supplier audits for Terumo Aortic and work with suppliers to provide effective actions to and findings
  • Development of effective internal & external customer relationships to ensure quality & regulatory compliance for the business
  • Support the Supplier Change Notification Program and facilitate changes to a timely conclusion.
  • Create, update and maintain Supplier Quality Engineering documentation to support all relevant compliance requirements
  • 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 and Distributors, ensuring all statutory requirements are fully defined
    • Develop & support supplier rating process & provide Quality input for 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 NCR’s 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 & QC, 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

The successful candidate will possess;

  • Relevant Science / Engineering Degree (equivalent experience may be considered)
  • Lead Assessor qualified to ISO 13485:2016
  • Proven experience in Quality Management Systems in a similar role within a medical device environment
  • Extensive experience in a global company within a highly regulated industry Medical Device, Bioscience or Pharmaceutical
  • Experience of MDSAP regulations and requirements
  • Experience of MDR regulations and requirements
  • Thorough knowledge of regulatory standards, Quality Management Systems & global regulations for medical devices
  • Proven analytical & problem-solving skills
  • Excellent facilitation, coordination, prioritisation, presentation & communication skills
  • Proven ability to manage & prioritise busy workload, meet deadlines & work in a pressurised environment

    Terumo Aortic have an excellent opportunity to join us a Senior Supplier Quality Engineer, this is an excellent role that will support processes to ensure robust, risk-based processes for supplier management to control & drive supplier continuous improvement initiatives.

     

    The main responsibilities of the role are;

  • Directly support the Engineering Leader -Supplier Quality  and take charge of key SQE deliverables with minimal supervision.
  • Lead Supplier audits for Terumo Aortic and work with suppliers to provide effective actions to and findings
  • Development of effective internal & external customer relationships to ensure quality & regulatory compliance for the business
  • Support the Supplier Change Notification Program and facilitate changes to a timely conclusion.
  • Create, update and maintain Supplier Quality Engineering documentation to support all relevant compliance requirements
  • 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 and Distributors, ensuring all statutory requirements are fully defined
    • Develop & support supplier rating process & provide Quality input for 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 NCR’s 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 & QC, 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
  •  

    The successful candidate will possess;

  • Relevant Science / Engineering Degree (equivalent experience may be considered)
  • Lead Assessor qualified to ISO 13485:2016
  • Proven experience in Quality Management Systems in a similar role within a medical device environment
  • Extensive experience in a global company within a highly regulated industry Medical Device, Bioscience or Pharmaceutical
  • Experience of MDSAP regulations and requirements
  • Experience of MDR regulations and requirements
  • Thorough knowledge of regulatory standards, Quality Management Systems & global regulations for medical devices
  • Proven analytical & problem-solving skills
  • Excellent facilitation, coordination, prioritisation, presentation & communication skills
  • Proven ability to manage & prioritise busy workload, meet deadlines & work in a pressurised environment