Location : Kuala Lumpur
Industry : Medical
Key Responsibilities :
- Develop qualification plans for supplier transfer projects and complete associated verification testing
- Manage and execute Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs)
- Collaborate effectively within engineering and cross-functional teams.
- Pull together design packages including drawings, specifications, and Bill of Material (BOM)
- Work with suppliers to understand requirements and answer technical questions
- Drive design changes (ECOs) to add alternate supplier or change the approved supplier
- Drive verification of transferred items and First Article Inspections (FAIRs)
- Partner with Modality engineers to understand scope and impact of the transfer
Requirements :
Background in Electrical or Mechanical Engineering (mix of Mechanical& Electrical Engineers ideal)Solid understanding of Medical Device Quality Management System (QMS) processes, with hands-on experienceProven experience managing end-to-end design change projectsElectrical Engineering background, preferably with medical device knowledgeDesign Change experience (Inputs, Requirements, Verification, Transfer)Ability to read and interpret engineering specifications, drawings, and BOMsInterested candidates, please email your resume to or call for more information at
Job Type : Full-time
Work Location : In person