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.
* 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.
Requirements:
* Minimum of 6+ years in medical device companies.
* Quality Engineering certification is an advantage.
* The ability to manage multiple priorities, while maintaining attention to details is critical.
* Good communication and team player.
* Self-learning ability, able to work independently as well as in a team.
* Excellent written and oral communication and presentation skills.
* Excellent computer skills (Word, Excel, PowerPoint and Outlook).
* Minimum of 6+ years in medical device companies.
* Quality Engineering certification is an advantage.
* The ability to manage multiple priorities, while maintaining attention to details is critical.
* Good communication and team player.
* Self-learning ability, able to work independently as well as in a team.
* Excellent written and oral communication and presentation skills.
* Excellent computer skills (Word, Excel, PowerPoint and Outlook).
This position is open to all candidates.
