Production Improvement Lead
2 weeks ago
The Equipment Qualification Manager will be responsible for ensuring that all process equipment/jig/fixture/tooling used by Production meets regulatory requirements and industry standards. This includes collaborating with NPI to qualify new equipment, analyzing unplanned downtime, and developing improvement plans to enhance productivity and reduce waste.
Responsibilities:- Qualify Equipment: Collaborate with NPI to qualify new process equipment/jig/fixture/tooling, ensuring compliance with regulatory requirements and facilitating smooth production processes.
- Analyze Downtime: Investigate and analyze unplanned downtime for process equipment/jig/fixture/tooling used by Production, proposing effective improvement plans to enhance productivity and reduce waste.
- Implement Change Management: Develop and implement change management plans to ensure successful transfer of qualified equipment to Production, minimizing disruptions and risks.
- Manage Vendor Relationships: Coordinate with vendors related to process equipment/jig/fixture/tooling used by Production, arranging site visits and necessary arrangements when required.
- 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 skills – familiar with Microsoft Office.
This position requires a highly detail-oriented individual with excellent analytical and communication skills to ensure compliance with regulatory requirements and drive process improvement initiatives.
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