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We are a well-funded medical startup transforming ICU care through advanced technology and innovation. Our smART+ platform is an intelligent, sensor-based solution that optimizes nutrition delivery while reducing the risks of ventilator-associated pneumonia and malnutrition. Supported by clinical trials, we are setting a new standard in critical care by achieving nearly 100% feeding efficiency and reducing ICU stays by an average of 3.3 days. We are looking for a talented Quality control engineer to join our collaborative and growing regulation team. The Certified Quality Engineer is a professional who understands the principles of product and service quality evaluation and control. As a member of the team, youll be responsible, Perform incoming inspection for items, including:
* Visual inspection and verify compliance to Purchas Order & Purchas Specification definitions.
* Measure and record the dimension of components/parts using measuring instruments and analyze the findings for discrepancy.
* Perform destructive TEST or hardness TEST (if necessary) and analyze findings and raise report where necessary.
* Perform in-process inspection according to procedures and products specifications.
* Perform final inspection of items as defined, to ensure that all quality requirements or specifications have been achieved and perform Lot Release.
* Work with Manufacturing and Engineering teams to investigate and resolve product quality issues and improve the First Pass Yield (FPY) for finished goods inspection, including leading MRB investigations.
* Prepare and/or update TEST procedures and work instructions whenever needed.
* Verify that production process and work instructions are followed.

Responsibilities:
Review of Contract ,Customer SOW and SPEC requirements to ensure compliance of design and production.
Approve gates review at R&D
PLCM (Project Life Cycle Management) - process control, full partnership in project management during the development, testing, production, customer delivery and customer support phases throughout the product life
Identifying regulatory Gaps in new and carrent projects
Perform Internal and External Audits
QA presence in R&D process (capacity) and ability to prevent errors in design
Follow up after R&D corrective and preventive actions and Improvement Plans
Transfer products from development to NPI and serial production (QA activities)
Review and approval ECO / MCO / ATP/ATR, Waiver relate to R&D , ENG
Writing QA procedures
FRACAS Management
Quality Assurance Program Plan (QAPP) and the Quality Allocation Tasks for the program.
Customer complince - relate to NPI , Pre production , design errors
Perform Quarterly data analysis for QBR.