Intersurgical is Europe’s leading designer, manufacturer and supplier of a wide range of medical devices for respiratory support. With over 40 years’ experience in this area, we understand the changing and challenging environment and needs of our customers. Innovation is an important aspect of our business in all areas, where quality is built-in from concept through to final product.
An exciting opportunity has arisen to join our thriving Medical Device Manufacturing Company and support our Strategic Development Programme.
Job Description
Validation is the process of establishing documentary evidence that production equipment/process maintains the desired level of compliance at all stages. Validation engineers create, plan and execute tests to verify if equipment/processes produce products that meet quality requirements, prevent and fix issues. This job is an interesting mix of office-based report writing, and production based assessments.
Location: Visaginas (Lithuania) / Validation Department / Quality Assurance Function
Main responsibility:
- Manage validation projects, coordinate and guide the execution of the validation activities.
- Develop and write validation documents following established standards and templates.
- Develop and run test protocols.
- Analyse and document test results.
- Develop and implement solutions to validation issues.
- Maintain validation documentation through the validation life cycle.
- Provide the relevant support for regulatory audits.
Requirements
- Bachelor’s degree (preferably in Engineering or other exact sciences discipline). If you are interested, but do not have required degree, you may apply anyway to discuss other possibilities.
- Good verbal and written communication skills in English and Lithuanian.
- Good computer knowledge: MS Word, MS Excel, MS Outlook.
- Ability to work and interact with various personnel.
Beneficial qualifications:
- Enthusiasm for working in a team – validation is a team activity and you will need good verbal and listening skills to share information amongst the team members.
- Preference for a structured approach to working – your work will affect others in the overall validation team.
- Attention to detail – it is vital to pay attention to every test result and measurement, noticing when something is not quite right.
- Analytical thinking – as well as identifying when there is an issue, part of the role can be to suggest why there might be an issue and potential fixes.
- Good written communication skills – protocol and report writing is an essential part of the job.
- Time management – there is a timeline that needs to be followed.
- Initiative – new and inventive ways may be needed to challenge the processes and fix problems.
We offer:
- Interesting and challenging work.
- Friendly environment and full training (internal: Instructor-led training, eLearning; external: webinars and online training).
- Great opportunity to develop skills and experience.
- Salary from 1800 to 2300 Eur before taxes (depends on background and experience).
