When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $25 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
Cramlington, UK – Single Use Technologies
How will you make an impact?
The QE Technician will play an integral role in our Quality Engineering Process Qualification group and customer complaint group. The QE Technician will execute the testing per the qualification protocol and assist Quality Engineers with inhouse testing for the customer complaints process.
What will you do?
- Support the validation function by assisting with validation documentation, executing qualification protocols and compiling data.
- Plan, resource and perform various testing procedures as needed for process inputs, outputs and parameters, as defined in the protocol.
- Responsible for supporting engineers in their projects and assist with technical reports.
- Record test results on standardized forms and writes test reports describing procedures used.
- Support Quality Engineers with customer complaint returns and associated testing.
- Work closely with the Operations group to provide technical support for products and processes
- Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance standards are achieved.
- Complete QA responsibilities in QMS systems.
- Provide an example of behavior and ethics to other technicians and ensure that all facility SOP's, policies and standards including, cGMP, ISO, and safety standards are followed.
- Other duties as assigned
How will you get here?
- Science based Degree desirable
- Related experience; preferable in medical device, biotech or pharmaceutical industry in an Engineering, Quality or Regulatory related role.
- Experience in a production environment.
- Direct experience of working within an ISO 13485 or ISO 9001 and 21CFR820 facility desirable
Knowledge, Skills, Abilities
- Strong analytical, problem solving, and teamwork skills are required.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Should be able to write neat and legibly. Ability to write routine reports and correspondence in a professional manner.
- Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements.
- Ability to analyze and process data and draw the appropriate conclusions.
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes
- Experience prioritizing conflicting demands
- Ability to analyze and process data, and draw the appropriate conclusions
- Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
- Excellent communication, written and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point, Teams.
37.5 hours per week, Monday to Friday
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
To Apply, please click the following link: https://thermofisher.contacthr.com/82343646
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