Interim Quality System Engineer
Do you want to become the person that the whole team will miss because of your enormous support? Would you like to learn everything from A-Z about Quality Management System? And do you have an excellent feeling for Quality? Then, this part-time, temporary role will be an experience of a lifetime!
Who are we?
Cassini Technologies pioneers innovative, superior corneal diagnostic solutions that are affordable, fast, and user-friendly, providing care providers worldwide with advanced technology that best serves their patients. Cassini helps cataract surgeons better understand the total cornea properties to improve outcomes and increase premium procedure volume and patient satisfaction.
Cassini Technologies is a dynamic company within the Ophthalmology space. Our Quality Management System is certified under the MDSAP program, and our product has obtained CE and FDA approval. Our product (Cassini Corneal Shape Analyzer) is sold to cataract surgery clinics directly and through a network of strategic partners (Ophtec, LENSAR and Johnson & Johnson Vision).
Cassini Technologies is looking for an ambitious Interim Quality System Engineer to strengthen the quality team and drive our commercial success internationally along with a highly talented team and an inspiring development roadmap.
What do we offer?
In the Interim Quality System Engineer role, you will work closely together with the R&D and QA/RA departments, responding rapidly and effectively to QA/RA-related issues. Through structured root cause analysis of technical support cases and your deep personal insight into our products’ performance, you will help the development team continuously improve our products further. In addition, you will be responsible for assisting QMS related tasks as assigned by QA/RA Manager. The successful candidate must possess strong IT skills and sound, precise communication abilities, as these are essential for the position. In addition, the candidate must have a can-do attitude and willingness to learn new regulations such as EU MDR (2017/745).
Location: At our head office in The Hague, Netherlands. The candidate must be based in the Netherlands and have a valid work permit.
Role & Responsibilities
- Ensure all Quality Documents meet document control requirements before processing documents in the Quality Management System.
- Ensure impacted stakeholders are involved in the review of new and revised Quality Documents.
- Maintain QMS databases and trackers.
- Archive and retrieve records.
- Update and maintain procedures, registers, and databases.
- Enter accurate meta-data into electronic records to facilitate easy search and retrieval.
- Assist in the production of reports and management of Device History Records.
- Assist in technical document preparation and QMS software validation.
- Support the QA/RA Manager to meet quality objectives.
- Preparing and Acquiring correct Management and QA/RA approvals where needed.
- Any other QA activities as defined by the QA/RA Manager.
- Technical competence, particularly with Excel and PowerPoint.
- Excellent organizational and communication (verbal and written) skills.
- Motivated with a positive attitude.
- Problem Solver.
- Ability to multitask and manage time effectively.
- Capable of handling an extensive range of information.
- Ability to achieve agreed objectives and targets.
- Have a passion for quality and an eye for detail.
- Eager to learn.
- Sufficient knowledge of the English language.
- Available for at least 20 weeks, 2-3 days per week.
- MBO or HBO in Engineering, Science or Technology related field.
Please email your Resume/CV to email@example.com
Only direct hiring allowed. Recruiters please excuse!