Supplier Quality Engineer
3 days ago
To be a technical focal point for the work cell to work on supplier quality issues directly with the Supplier Quality Engineering group and communicate status on non-conforming parts/suppliers across the work cell product at the site level.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Ensure that all non-conforming materials held in Receiving Inspection are released to stock or production floor in a timely manner. Provide feed back of issues encountered to Supplier Quality Engineer II.
- Provide guidance to Receiving Inspectors.
- To provide documentation to perform Inspection of components per Inspection Plans in SAP.
- To be the focal person for work cell related quality and functional product issues that stem from components being purchased for manufacturing.
- Evaluate component failure rates from production line, collect samples and initiate Failure analysis to drive continuous improvement activity to component manufacturer.
- Assure that non-conforming materials to be returned to vendor due to poor quality have the appropriate documentation that describes the reasons for return (5W, 2H).
- Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
- Comply and follow all procedures within the company security policy.
Degree or Diploma in Mechanical Engineering or a similar discipline and preferably at least 2 years in Medical Device Manufacturing.
Well verse in ISO13485:2016, MDSAP and will be advantage with knowledge of the FDA inspection and requirements.
Technical knowledge in quality control and assurance to effectively assess and manage supplier quality and performance.
Strong analytical skills to evaluate suppliers' methods, materials, and products, and to resolve any issues that arise.
Exceptional communication skills to interface with suppliers and cross-functional teams, reporting on supplier performance, and discussing quality improvement strategies.
Attention to detail and organizational skills to monitor and keep track of multiple suppliers and their performance metrics simultaneously.
Problem-solving skills to identify and address quality issues, devise improvement strategies, and implement corrective actions with suppliers.
Understanding of industry-specific regulations and standards, such as ISO 9001, ISO13485 to ensure supplier compliance.
Project management abilities to coordinate and lead supplier quality-related projects, ensuring they are completed on time and within budget.
Proficiency in using quality inspection tools and software for data analysis and reporting.
Mandarin fluency required to liaise with Mandarin-speaking stakeholders.
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