Do you want to shape and contribute to the future of healthcare? Siemens Healthineers are looking for a Validation Quality Engineer to join their Healthcare Diagnostics business based at the well-established and modern facility in Llanberis, located next to Snowdonia National Park. The facility manufactures and distributes reagents for in-vitro diagnostic medical devices used in hospitals worldwide to aid the diagnosis of medical conditions.
As part of this role you will ensure compliance with ISO 13485, FDA 21 CFR, ISO 14971 and any other applicable International Regulatory requirements in terms of validation, control of non-conforming product, risk management and supplier quality assurance.
- Generation and independent review of validation lifecycle deliverables and documentation as required to ensure 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 FMEA activities within assigned business departments to ensure compliance and continuous improvement of the business.
- 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 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.
Skills & Experience:
- Understanding of quality techniques and best practice relating to: validation, control of non-conforming product, CAPA, risk management and supplier Quality Assurance.
- Understanding Immunodiagnostic product realisation process.
- Experience working in a regulated environment ideally diagnostics or medical.
- Perform work in compliance with established procedures and GMP.
- Should be 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
- Use of statistical techniques for data analysis.
Being part of our team:
In Llanberis, Siemens Healthineers is the sole manufacturer of IMMULITE reagents, used in IMMULITE blood analysers to aid the diagnoses and treatment for patients – more information can be found here.
Siemens Healthineers has been Certified™ as a ‘great place to work’. We are inspired to transform the way things are done – because we want what is best for our people, our customers, and ultimately to help everyone live longer and healthier lives. To find out more about our business and recent news, please explore our website.
- A competitive salary
- Generous pension contributions
- 26 days holiday
- Access to our flexible benefits from private medical insurance to dental cover
- Corporate Social Responsibility opportunities including 2 paid volunteering days per year
- Support from our 24/7 employee assistance programme
In addition, we provide a flexible and dynamic environment with the space to stretch beyond your comfort zone in order to grow both personally and professionally. Our unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we want you to seek, implement and celebrate your best ideas.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Products Ltd
Experience Level: not defined
Job Type: Full-time