Quality Engineer

Job description

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

The Quality Engineer will ensure compliance with ISO13485, 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.

Responsibilities include:

· Generation and independant 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 process, performance and maintenance 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, CAPA, calibration, risk management and supplier quality assurance within assigned business departments to ensure compliance and 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 issues.
· To ensure QE activities remain in line with company current processes and procedures, including health & safety.
· Develop & maintain QE supporting systems and appropriate procedures and other user documentation.

Qualifications & Experience:

· Understanding of quality techniques and best practice relating to: validation, control of non-conforming product, CAPA, calibration, risk management and supplier quality assurance.
· Understanding of immunodiagnostic product realisation process.
· Experience of using statistical techniques for data analysis.
· Training & mentoring experience.
· Performing work in compliance with established procedures and GMP.
· Experience using computer software including, Word, Excel & Access.
· Understanding of QE processes.
· Experience / understanding of working in a regulated environment.
· Educated to a degree or higher national level in engineering or scientific subject and / or have equivalent time served experience within a quality, scientific or engineering environment

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.