We are hiring a highly dedicated Process Engineer who will be responsible to manage all qualification activities related to process equipment/ jig/ fixture/ tooling used by Production and all process improvement activities related to Production processes for our Medical Device/Pharmaceutical sector.
Job Responsibilities:
- Review and update routing and product structure related to Production processes.
- Analyze unplanned downtime for process equipment/ jig/ fixture/ tooling used by Production and propose improvement plan.
- Manage co-ordination activities with vendor related to process equipment/ jig/ fixture/ tooling used by Production and to make necessary arrangements when vendor is required to work onsite.
- Collaborate with NPI on process development for new projects and qualification of new process equipment/ jig/ fixture/ tooling.
- Analyze and lead investigation activities initiated from non-conformances related to Production processes.
- Lead troubleshooting and/ or testing activities on process equipment/ jig/ fixture/ tooling when requested by Production.
- Lead Production process improvement activities and manage the required activities till they are successfully implemented and transferred to Production.
- Update and maintain relevant documents / recording system related to process equipment/ jig/ fixture/ tooling, in line with current practice and QMS requirements.
- Responsible in the preparation works for audit or onsite visit/ tour.
Job Requirements:
- Degree level education in Engineering or Science or equivalent.
- Minimum 2 years’ working experience preferably in the related field in manufacturing or medical industry.
- Knowledge of ISO 13485 and GMP is an advantage.
- Able to lead and work in a team with minimum supervision
- Good written and spoken English and Bahasa Malaysia.
- Computer skill – familiar with Microsoft Office.
Are you ready to make that career shift? Trust us, this role is always on-demand and you will grow a great portfolio with us.
