Our smART+ platform is a sensor-based feeding system for intensive care unit (ICU) patients. It aims to prevent life-threatening complications such as ventilator-associated pneumonia, malnutrition, and acute kidney injury. We recently introduced Nutrition Management 2.0, which is a comprehensive, guideline-driven approach that aims to improve nutrition while reducing feeding complications. Combined with our smART+ platform, it monitors, analyzes, and prevents malnutrition and gastric aspirations in real time. By improving nutrition and achieving 100% feeding efficiency, the smART+ platform greatly reduces hospital-acquired complications and speeds up ICU patient recovery. This is a temporary position (Maternity Leave Cover) for a period of 8-9 months, with an option to extend to permanent employment. The QA Engineer Non-Conformity Leader shall have a responsibility that includes:
* Provide Technical Support in documenting & maintaining the Quality Management system through knowledge & understanding of ISO13485 & MDR.
* Alert management on critical issues and delay in tasks closure.
* continues improvements on the relevant processes.
* Co-operate with RA/ QA / QC team to comply with regulations.
* Provide Technical Support in documenting & maintaining the Quality Management system through knowledge & understanding of ISO13485 & MDR.
* Review requirements, specifications and technical design documents to provide timely and meaningful feedback.
* Suppliers- Control, monitor and approve all suppliers, perform and approve supplier evaluation, etc.
* Customers- analyzing issues reported via customer feedback, maintaining records and implementing changes to manufacturing when necessary.
* Support QMS- logistic activities for compliance with the approved written procedures and requirements.
* Discussing and solving problems related to manufacturing departments, sub-contractors, suppliers and customers.
* Assist with the development and implementation of regulatory procedures.
* Provide Technical Support in documenting & maintaining the Quality Management system through knowledge & understanding of ISO13485 & MDR.
* Alert management on critical issues and delay in tasks closure.
* continues improvements on the relevant processes.
* Co-operate with RA/ QA / QC team to comply with regulations.
* Provide Technical Support in documenting & maintaining the Quality Management system through knowledge & understanding of ISO13485 & MDR.
* Review requirements, specifications and technical design documents to provide timely and meaningful feedback.
* Suppliers- Control, monitor and approve all suppliers, perform and approve supplier evaluation, etc.
* Customers- analyzing issues reported via customer feedback, maintaining records and implementing changes to manufacturing when necessary.
* Support QMS- logistic activities for compliance with the approved written procedures and requirements.
* Discussing and solving problems related to manufacturing departments, sub-contractors, suppliers and customers.
* Assist with the development and implementation of regulatory procedures.
Requirements:
* Degree in Biomedical / Science / Biotechnology / Engineering or equivalent.
* At least 4 years of experience as a QA Engineer in a Medical Device company.
* Proven experience with manufacturing process – Process validation, review of work instructions, drawings, RR etc.
* Analytic capabilities, detail, and task oriented.
* Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly.
* Strong verbal and written communication skills in English.
* Degree in Biomedical / Science / Biotechnology / Engineering or equivalent.
* At least 4 years of experience as a QA Engineer in a Medical Device company.
* Proven experience with manufacturing process – Process validation, review of work instructions, drawings, RR etc.
* Analytic capabilities, detail, and task oriented.
* Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly.
* Strong verbal and written communication skills in English.
This position is open to all candidates.
