Supplier Quality Engineer

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 Healthcare Diagnostics Products Ltd

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

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.

Your Expertise:

• Previous experience in a supplier facing Quality Engineering role.
• 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.
• 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

Who we are:

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.