Supplier Quality Engineer — IVD & Regulatory Focus

ITH Icoserve; Llanberis; On-site; GBP 40,000 - 60,000; Full time

Benefits offered by this job

26 days holiday

Pension contribution

Share and bonus scheme

Private medical insurance

Dental cover

Volunteer days

EAP

Job summary

Siemens Healthineers has an opening for a Supplier Quality Engineer at our Llanberis, Gwynedd site. The role focuses on maintaining high quality parts from suppliers within an ISO 13485 and FDA-regulated environment.

You will develop world-class supply chain processes and manage supplier performance, driving root cause investigations and corrective actions while supporting technology transfer and new projects. A robust quality mindset and strong communication skills are essential.

Qualifications

• Proven experience in a supplier facing Quality Engineering role.
• Experience across the whole supply chain including supplier environments.
• Excellent communication skills, both oral and written.
• Auditing experience to ISO 9004:2015 and ISO 13485:2016.
• Ideally working knowledge of Six Sigma, Statistical Analysis and Lean principles.

Responsibilities

• Develop world-class supply chain processes between low-volume, high-complexity tech and higher-volume reagents.
• Manage suppliers to deliver quality products to internal customers via investigations and evaluations.
• Liaise with external suppliers to ensure training and adherence to requirements.
• Issue Supplier Corrective Action Reports and drive root cause investigations and corrective action.
• Conduct Supplier Performance Reviews and report key supplier quality metrics.
• Support technology transfer initiatives and assess new suppliers as applicable.
• Provide day-to-day inspection expertise to Goods Inwards Inspection and interface with suppliers.
• Contribute to continuous development of the quality system and SOP documentation.
• Oversee KPIs for supplier quality oversight and ensure requirements are met.

Skills

Supplier quality

Auditing

Communication

Six Sigma

Lean

Job description

Siemens Healthineers has an opening for a Supplier Quality Engineer at our Llanberis, Gwynedd site. The role focuses on maintaining high quality parts from suppliers within an ISO 13485 and FDA-regulated environment.

You will develop world-class supply chain processes and manage supplier performance, driving root cause investigations and corrective actions while supporting technology transfer and new projects. A robust quality mindset and strong communication skills are essential.