Overview
An exciting opportunity to join our dynamic team responsible for the R&D of In Vitro Diagnostics products. We develop a diverse range of IVD products, including analytical and medical devices, and are responsible for activities such as product development, verification and validation, and on-market support.
Key Responsibilities
* Design and conduct verification and validation studies in the laboratory for In Vitro Diagnostics products.
* Develop, test and refine prototype products, ensuring compliance with current technical guidelines and quality management system requirements.
* Generate test protocols, review and analyze results, and generate V&V reports.
* Plan day-to-day activities, ensure sufficient supplies, and organize proficiency testing within the laboratory.
* Carry out work in accordance with defined processes and laboratory procedures.
* Ensure all work is compliant with existing quality processes.
* Perform investigative work to support reagent kits.
* Maintain detailed experimental records.
* Create and revise laboratory SOPs as required.
* Travel to other sites or countries for knowledge transfer.
In return, you will receive:
* Learning and development opportunities to further your career.
* A competitive salary and benefits package.
* Opportunities for professional growth and advancement.
Requirements
* Proven experience working in a laboratory with analytical equipment such as HPLC or UPLC.
* Ability to operate under a Quality System and knowledge of Good Laboratory Practice (GLP).
* Experience working in an R&D environment (pharmaceutical or medical device) would be advantageous.
* Familiarity with basic laboratory procedures and Microsoft Excel skills.
Desired Experience:
* Product development and design experience.
* Understanding of quality management systems (ISO13485 & 21CFR820).
* Knowledge of Non Conformance, Change Control and CAPA systems.