Technical Operations Scientist - IVDR
We are recruiting for a Technical Operations Scientist to join our healthcare diagnostics team. The role is 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 key responsibility of the role is to collate product technical data and generate technical reports necessary to meet the requirements of the European In-Vitro Diagnostics Regulation (IVDR). The role is within the Technical Operations team, and will working closely with the Quality, Regulatory and other functions in order to complete the necessary reports to the agreed schedule and answer any queries that may arise.
This is a 2 year contract to work on a specific project.
Design, direct, organise and implement actions required to generate technical product dossiers
Design analytical experiments with the aim of generating the necessary information to complete the requirements of the technical product dossiers
Review, assess and, where required, perform suitable statistical analysis on data generated as a consequence of or in relation to a technical product dossier.
Interpret, summarise and present results to the required standard.
Awareness of priorities and deadlines and ensure work is assigned and organised to maximise efficiency according to these priorities.
Write and circulate technical reports. Generate reports and participate in meetings to support the relevant processes.
Involvement in risk assessment activities as required to support the requirements of the site.
To communicate effectively with all levels of staff within and outside of the department in a timely manner with regards to allocated task status.
Demonstrate a positive and professional attitude towards workplace, co-workers, Company Policies and Procedures.
To comply with all Company Health and Safety Policies and Procedures. To highlight any real or potential health and safety issues to management and assist in actioning their decisions.
To comply with relevant Quality and Environmental Standards and European Directives as documented within Company Quality Management Systems.
What do I need to qualify for this role?
Post-graduate or graduate in a science discipline or relevant industry experience.
Demonstrable experience in environment with Immunoassay, problem solving or data analysis tasks
Experience with laboratory skills and practices.
Great communication skills, written and verbal.
Experience of analysis tools and techniques and statistical software packages.
Project management experience
Good attention to detail, time management skills and teamwork.
We at Siemens Healthineers are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 48,000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.
In order to push the boundaries in our exciting and challenging industry, our shared sense of common purpose guides our decisions and day-to-day work. We work in a flexible and dynamic environment that allows for our own priorities. And while we respect each other’s individuality, we are proud of the high level of team spirit we share.
We offer 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.
Job ID: 70870
Organisation: Siemens Healthineers
Experience Level: not defined
Job Type: Full-time