Responsible for Engineering work activities on handling daily issues in the production line, manufacturing documentation, new process transfer into production, and process improvement.
Responsibilities
In-charge of engineering support for production and ensuring that it meets the daily target on quality, output, yield, and delivery.
Ensure compliance with QMS, cGMP, and regulatory requirements in manufacturing activities.
Ensure that goods and services are produced at the production at right efficiency, cost, and level of quality.
Perform process, software, and equipment validation. (IQ, OQ, PQ, etc.)
Establish, update and maintain process documentation. (WI, form, drawing, BOM, Risk Assessment, Risk Management, etc.).
Maintain the label printing process. (Label printing artwork)
Conduct manufacturing process training for production staff.
Lead a team to investigate and analyse the root cause of process issues and non-conformances. Implement and evaluate the effectiveness of corrective and preventive actions.
Work on continuous improvement activities in the manufacturing line and follow up with the implementation.
Support for the transfer of new processes and products into the production phase.
Build a teamwork culture.
Other related duties as assigned.
Requirement
Minimum a Bachelor's Degree in Mechanical/Industrial/Manufacturing Engineering or equivalent.
Minimum 2 years of work experience in medical device manufacturing will be advantageous.
Knowledge and competency in Risk Management, EN ISO 14971
Basic knowledge of the engineering methodology such as LEAN, 5S, and Six Sigma.
Basic knowledge of project management, process validation strategy, and quality tools.
Ability to manage the project and complete it on time.
