Process Engineer (Medical Device)

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 medical device manufacturing industry.

Knowledge of ISO 13485 and GMP is an advantage.

Knowledge of injection moulding is an added 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.