Supplier Quality Engineer

Siemens Aktiengesellschaft; Porthmadog; On-site; GBP 42,000 - 62,000; Full time

Benefits offered by this job

26 days' holiday (option to buy/sell 5

Employer pension up to 10%

Share and bonus scheme

Private medical insurance and dental

CSR volunteering days (2 per year)

24/7 employee assistance programme

Job summary

Siemens Healthineers in Llanberis, Gwynedd, North Wales, is seeking a Supplier Quality Engineer to strengthen our supplier quality management in ISO 13485 and FDA-regulated environments. The role collaborates with engineering, production and procurement to ensure parts and components meet stringent quality standards.

You will lead supplier assessments, root-cause investigations, and performance reviews, support technology transfer, and contribute to continuous improvements of SOPs.

Qualifications

• Experience in ISO 13485 and FDA 21 CFR Part 820.
• Auditing experience with quality systems.
• Cross-functional collaboration across engineering, production and procurement.
• Knowledge of supplier quality metrics and CAPA processes.
• Strong communication and problem-solving abilities.

Responsibilities

• Develop supplier quality processes for a low volume, high complexity environment.
• Manage suppliers to deliver quality products to internal customers.
• Liaise with external suppliers to ensure training and compliance with requirements.
• Issue Supplier Corrective Action Reports and conduct root-cause investigations.
• Conduct supplier performance reviews and report KPIs.
• Support technology transfer initiatives and supplier selection.

Skills

Supplier QC

ISO 13485

FDA 820

Root cause

Auditing

Six Sigma

Education

HNC/Diploma/Degree

Job description

Siemens Healthineers has an opening for a Supplier Quality Engineer at our In-Vitro Diagnostic (IVD) instrumentation / reagent manufacturing site in Llanberis, Gwynedd, North Wales. The Supplier Quality team works cross functionally with engineering, production, and procurement with responsibilities focused on maintaining a high level of delivered quality parts from our suppliers. This role will support our supplier quality management services within an ISO 13485 and FDA 21 CFR Part 820 regulatory environment. Your Role:

• To develop world-class supply chain processes between a low volume, high complexity multi-technology environment (diagnostic instrumentation) and a higher volume allergen manufacturing (reagents.)
• To manage our suppliers to deliver quality product to our internal customers, through product & process investigations & evaluations.
• Liaising with a wide variety of external suppliers to ensure suppliers are trained and adhere to Siemens First Articles, Quality and Regulatory requirements.
• Issuing of Supplier Corrective Action Reports and working with suppliers on Root Cause Investigations and Corrective action.
• Conducting Supplier Performance Reviews and Reporting of Key Supplier Quality metrics.
• To support technology transfer initiatives and new projects. Involving the assessment and selection of new suppliers where applicable.
• To provide day to day inspection expertise support to the Goods Inwards Inspection Team in the areas of Component and Mechatronic Inspection and acting as a technical reference to interface with the supplier.
• To contribute to the continuous development of the quality system, including standard operating procedures (SOP's) coupled with the ability to write concise technical reports.
• Support a Strong Supplier focus to ensure that that our requirements are met appropriately and oversee relevant KPIs for supplier quality oversight. Previous experience in a supplier facing Quality Engineering role.
• HNC/Diploma/Degree in an appropriate discipline OR commensurate experience.
• Ability to work in technically complex areas across the whole supply chain, including the supplier environment.
• Excellent Communication skills both oral and written.
• Auditing experience to both ISO 9004:2015 and ISO 13485:2016.
• Ideally have a working knowledge of Six Sigma, Statistical Analysis and Lean principles for investigations, problem solving and continuous improvement. We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

• 26 days' holiday with the option to buy or sell an additional 5
• Up to 10% employer pension contribution
• Share and bonus scheme
• Access to our flexible benefits from private medical insurance to dental cover
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme