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
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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