Supplier Quality Engineer – IVD Medical Devices, Global Impact

Siemens Mobility; Llanberis; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

26 days holiday

Pension contribution up to 10%

Share and bonus scheme

Private medical insurance

Dental cover

CSR volunteering days

Job summary

Siemens Healthineers is seeking a Supplier Quality Engineer for our Llanberis, Gwynedd site. You will support supplier quality management in an ISO 13485 and FDA 21 CFR Part 820 environment, coordinating with engineering, production and procurement to ensure high-quality parts from suppliers.

You will develop supply chain processes for a low-volume, high-complexity technology environment and manage supplier performance, supporting technology transfers and new projects, while ensuring compliance

Qualifications

• Experience in a supplier-facing Quality Engineering role.
• Excellent oral and written communication skills.
• Auditing experience to ISO 9004:2015 and ISO 13485:2016.
• Knowledge of Six Sigma, statistics and Lean for investigations and continuous improvement.

Responsibilities

• Develop world-class supply chain processes between low-volume, high-complexity multi-technology environments and 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 lead Root Cause Investigations and corrective actions.
• Conduct Supplier Performance Reviews and report Key Supplier Quality metrics.
• Support technology transfer initiatives and assess/select new suppliers when applicable.
• Provide day-to-day inspection expertise to Goods Inwards Inspection Team and interface with suppliers.
• Contribute to continuous development of the quality system and SOPs.
• Oversee KPIs for supplier quality oversight.

Skills

Supplier quality engineering

Communication skills

Auditing ISO 9004/13485

Six Sigma / Lean knowledge

Job description

Siemens Healthineers is seeking a Supplier Quality Engineer for our Llanberis, Gwynedd site. You will support supplier quality management in an ISO 13485 and FDA 21 CFR Part 820 environment, coordinating with engineering, production and procurement to ensure high-quality parts from suppliers.

You will develop supply chain processes for a low-volume, high-complexity technology environment and manage supplier performance, supporting technology transfers and new projects, while ensuring compliance