Senior Supplier Quality Engineer in Inchinnan

Location: Inchinnan

Salary: Hidden

Recruiter: Terumo Aortic

Job Hours: Full-time

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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 :6

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