Quality Engineer

Quality Engineer

Llanberis, North Wales

Competitive salary + excellent benefits

Job ref: 178960

We are currently recruiting for a Quality Engineer to be based at our well-established and modern manufacturing and distribution facility based at Llanberis, Wales. The facility, based in the Snowdonia National Park, manufactures and distributes reagents used in hospitals worldwide to aid the diagnosis of medical conditions.

The Quality Engineer will ensure compliance with ISO 13485:2003, FDA 21 CFR Part 820 and other International Regulatory requirements in terms of validation, control of non-conforming product, calibration, risk management and supplier quality assurance.

What are my responsibilities?

· Generation and independent review of validation lifecycle deliverables and documentation as required ensuring compliance with regulatory authorities and fitness for purpose of business systems and equipment.

· Providing QE support and independent review for the control of non-conforming product/systems to ensure compliance and continuous improvement of the business.

· Provide QE support and independent review for risk management activities within assigned business departments to ensure compliance and continuous improvement of the business.

· Represent QE in the companies supplier selection, performance and maintenance process to ensure compliance and fitness for purpose of suppliers.

· Involvement in and, where appropriate, leadership in various improvement projects in relation to validation, control of non-conforming product, calibration, risk management and supplier quality assurance within assigned business departments to support continuous improvement of the business. Where appropriate this will require development of optimisation and notebook studies.

· Liaise with SHD affiliates with regards to any validation, control of non-conforming product calibration, risk management and supplier quality assurance issue.

· To ensure QE activities remain in line with company current processes and procedures, including health and safety.

· Develop and maintain QE supporting systems and appropriate procedures and other user documentation.

What do I need to qualify for the role?

· Understanding of quality techniques and best practice relating to: validation, control of non-conforming product, CAPA, calibration, risk management and supplier quality assurance

· Understanding Immunodiagnostic product realisation process

· Experience of using of statistical techniques for data analysis.

· Training and mentoring experience

· Perform work in compliance with established procedures and GMP

· Understanding of computer software including Word, Excel and Access

· Understanding of QE processes.

· Experience/understanding of working in a regulated environment is desirable.

· Educated to Degree or Higher National Level in an Engineering or Scientific subject and/or and have equivalent time served experience within a Quality, Scientific or Engineering environment.

About Siemens

This role forms part of the Siemens Healthcare sector, and is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, medical information technology and hearing aids. By optimising clinical workflows for the most common diseases, Siemens makes healthcare faster, better and more cost-effective.

Siemens, the leading global engineering and technology services company, has been active in the United Kingdom for over 170 years. We provide innovative solutions to help tackle the UK’s major challenges, across the key sectors of energy, industry, infrastructure & cities and healthcare. Siemens has a significant presence throughout the UK, with 12 manufacturing sites and more than 25 major offices.

What else do I need to know?

Siemens is dedicated to quality, equality, and valuing diversity, and we welcome applications that reflect the diversity of the communities within which we work.

Siemens offers a comprehensive reward package which includes a competitive basic salary, bonus scheme, generous holiday allowance and pension. Through our flexible benefits scheme you can select benefits that best suit your lifestyle, including private healthcare.

How do I apply?

To find out more and apply please visit the Siemens career site by clicking on the apply button