Medtronic Quality Engineer in Singapore, Singapore
Singapore, Singapore, Singapore
5 days ago
Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies' requirements. Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products. Participate on internal, inter-facility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.
Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.
Actively participate in the qualifications and validations of product/equipment and processes.
Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers through evaluation/approval of Engineering change request/orders. Ensure update of manufacturing processes in order to reflect quality concepts and specification requirements.
Apply statistical tools in order to assure that processes comply with the specifications.
Conduct failure investigations in order to initiate, stimulate, and assign corrective action. Issue written reports and update, accordingly.
Review and analyze quality trends with the manufacturing team. Analyze data based on trends, recommend actions for process, equipment and system improvement.
Evaluate product/material discrepancies. (PRB/MRB) on time, and implement corrective actions accordant.
Establish mechanism to evaluate, measure, monitor and/or quality in our products.
Perform risk assessment activities with reliability for product quality risks.
Work on special projects assigned by Supervisor/Manager.
Flexible and adaptable
Patience and perseverance
Experience and Knowledge:
Minimum 3 years’ experience in Engineering related to manufacturing of small electro/mechanical devices preferably in a quality assurance or test related capacity.
Must have an aggressive practical personality capable of recognizing problems, causes, and solutions.
Understanding of Statistical Process Control and use of Minitab
- Bachelor Degree in Engineering or equivalent