Summary
Responsible for Engineering work activities on handling daily issues in the production line, manufacturing documentation, new process transfer into production, and process improvement.
Roles and 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.
Requirements
- 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.
- Fresh graduate is acceptable.
- 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.
- Good communication, and teamwork skills.
- Good interpersonal skills.
