Quality Assurance Validation Specialist
Radiometer Turku Oy
Would you like to work in an exciting environment in a fast growing company with a team of experienced QA professionals contributing to our ambitious strategic growth targets? You might just be the talent we are looking for - come join us!
You will be working in close collaboration with Capacity & NPI projects to support our capacity growth, facility expansion and design transfer of new products and equipment into production.
To succeed in this position we appreciate you to have:
- knowledge of quality management system and regulatory requirements of IVD industry, especially ISO13485 and FDA/QSR, including 21CFR Part 11
- relevant industrial work experience with strong focus on validation experience, including equipment and software validations
- ability to apply standards and regulations into practice
- capacity to structure existing processes and ability to develop new working methods
- personal qualifications: team player with good interaction skills; ability to take initiative and be decisive; good problem solving skills
- experience working with different stakeholders
- knowledge of immunoassay technologies is an advantage
Main responsibilities of the position are management of validation processes, review and approval of validation plans and reports and improvement of validation procedures. Position will support and maintain implementation of LIMS (Laboratory Information Management System) and implementation of other automated processes and electronic databases. You will contribute to QA team’s process improvement activities to ensure compliance and to support our strategic growth.
For further information, please contact QA Manager Pauliina Niemelä by e-mail at firstname.lastname@example.org or by phone +358 44 260 1702 (best available and April 1st-5th, 2019 at 14.00-16.00).
Please submit your application, resume and your salary request to email@example.com by April 12th, 2019. Recruitment will be completed as soon as suitable candidate is found.