Global Supplier Quality Engineer – IVD & Regulatory

Siemens Healthineers; Llanberis; On-site; GBP 42,000 - 62,000; Full time

Benefits offered by this job

26 days' holiday with option to buy/s-

Up to 10% employer pension

Share and bonus scheme

Flexible benefits: private medical, or

CSR volunteering days + EAP

Job summary

Siemens Healthineers in Llanberis, Wales, is seeking a Supplier Quality Engineer to strengthen supplier quality management within an ISO 13485 and FDA-regulated environment. You will collaborate with engineering, production and procurement to ensure high-quality parts from suppliers meet internal standards.

This role supports technology transfer, supplier audits, root-cause investigations and cross-functional collaboration to drive continuous quality improvements across the supply chain at our

Qualifications

• Previous experience in a supplier facing Quality Engineering role.
• Ability to work in technically complex areas across the whole supply chain.
• Excellent communication skills both oral and written.
• Auditing experience to ISO 9004:2015 and ISO 13485:2016.

Responsibilities

• Develop world-class supply chain processes between a low volume, high complexity multi-technology environment and a higher volume allergen manufacturing (reagents).
• Manage suppliers to deliver quality products through investigations and evaluations.
• Liaise with external suppliers to ensure training and adherence to First Articles, Quality and Regulatory requirements.
• Issue Supplier Corrective Action Reports and work with suppliers on root cause investigations and corrective actions.
• Conduct Supplier Performance Reviews and reporting of Key Supplier Quality metrics.
• Support technology transfer initiatives and projects; assess and select new suppliers.
• Provide day-to-day inspection expertise support to Goods Inwards Inspection Team for Components and Mechatronic Inspection.
• Contribute to continuous development of the quality system and SOPs; write concise technical reports.
• Oversee KPIs for supplier quality oversight and ensure requirements are met.

Skills

Supplier quality engineering

Auditing ISO 13485

Communication skills

Complex supply chain

Education

HNC/Diploma/Degree

Job description

Siemens Healthineers in Llanberis, Wales, is seeking a Supplier Quality Engineer to strengthen supplier quality management within an ISO 13485 and FDA-regulated environment. You will collaborate with engineering, production and procurement to ensure high-quality parts from suppliers meet internal standards.

This role supports technology transfer, supplier audits, root-cause investigations and cross-functional collaboration to drive continuous quality improvements across the supply chain at our