Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, the first capsule- based system for preparation-free, colorectal cancer screening. Utilizing innovative ultra-low dose X-ray and wireless communication technologies, our capsule generates information on the contours of the inside of the colon as it passes naturally. This information is used to create a 3D map of the colon, which allows physicians to look for polyps and other abnormalities. Designed to improve the patient experience and increase the willingness of individuals to participate in recommended colorectal cancer screening, C-Scan® removes many frequently-cited barriers, such as laxative bowel preparation, invasiveness, and sedation.
If you are passionate about medical devices which will influence millions throughout the world, we are offering a unique and great opportunity for talented people, to help us build and ensure our products meet the highest standards.
we are looking for supplier quality engineer to join our company.
- Manage and implement annual Supplier audit plan, Audits Response, support regulatory audits, Audit and certify suppliers to required standards
- Supports contract manufacturers and supplier quality activities and monitors production and compliance key process indicators.
- Supports new product introduction activities including process, equipment, SW and environment validations, production risk management, control plans component qualification and staff training.
- Analyze complaints and prepare response to related bodies.
- Analyze production Yield & cost of Quality.
- Overview follow up and guidance of routine QA/ QC activities such as CAPA, MRB, RMA, SCAR, incoming inspection, in process inspection, final inspection, product release.
- Defines and implement policies and procedure for inspections, rejects& process Validation including IQ, OQ & PQ.
- Work with Purchasing to ensure supplier performance is regularly reported and that appropriate and timely corrective actions are implemented
- Maintain and update critical supplier audit system and schedule
- Conduct supplier audits to drive process standardization, waste elimination, and continuous improvement
- Establish specific short / long term supplier quality goals
- Champion problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances
- Work to resolve supplier technical issues in a timely manner to ensure continuity of supply
- Develop long‐term supplier relationships and generate and implement cost reduction ideas
- Aide Manufacturing in the evaluation and qualification of new supplier materials following a defined new product development process
- Strategically lead supplier performance improvement projects in an effort to increase the supplier capability of consistently meeting Check-Cap requirements. Projects may include process analysis, value stream mapping, process capability and throughput analysis
- Drive “Zero Defect” mentality within the supply base.
Qualified candidates must meet the following requirements:
- At least 5 years related experience in medical device and training in design & development, manufacturing environment & Suppliers management; Knowledge in MDD, MDR, QSR, ISO13485, and ISO14971.
- Understanding of process validation principles, including experience with master validation plans, installation qualifications, operational qualifications, process qualifications, and test method validations.
- Strong knowledge in CAPA, NCMR, RMA, Labeling, Rework and Batch release processes.
- Strong written and verbal communication skills
- Advanced computer skills using Microsoft Office applications
- Strong problem-solving skills
- Strong organizational skills