Position Description

Quality System Specialist (Global Medical Devices MNC) @ East
Job Code 18935
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
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  • Global Medical Devices MNC
  • Working Location: East



  • Lead and/or provide support in the establishment of appropriate master data settings to facilitate product ramp-up or phase-out strategies
  • Collaborate with local and global teams to ensure that product lifecycle strategies are implemented properly in the SAP system
  • Ensure alignment of Material master and Product settings in Factory works and Enovia
  •  Develop, maintain and support of local MSO procedures to manage Product Lifecycle process
  • Work closely with Quality/Engineering/Supply chain to gather relevant information on Materials/ BOM and Routings for new products/materials.
  • Determining correct new materials attribute, products attribute and Bill of Materials.
  • Support activities to drive Master data alignment across various systems including Factory works, SAP, Indysoft and Enovia.
  • Lead & overseeing the configuration activities related to product or process changes
  • Support the collaboration of Master Data Governance
  • Play a Change Coordinator role as a Quality representative to coordinate the change communications according to the change control process. This includes interactions with change initiators/process owners/Quality/Regulatory and external partner as necessary.
  • Lead and execute change control processes and systems for improvement.
  • Assure the process and product change control process complies with Quality Systems Regulations and ISO standards
  • Work with Business Unit Regulatory and other applicable functions to complete deliverables prior to implementing change.
  • Work with Change Owners on the change implementation and ensure changes are track accordingly.
  • Be the focal point for any manufacturing change request that need evaluation and assessment.
  • Act as the Site Coordinator for MSO for change control and Chair for CCB meeting.



  • Min Bachelor’s Degree in Engineering qualification is required
  • At least 2 years’ experience of quality system background in healthcare industry, manage change control & product changes
  • Experience in managing change control of such systems is added advantage
  • Experience with regulatory documentation and procedures is added advantage
  • Experience in software validation, UAT and documentation of test cases will be added advantage
  • Ability to learn the manufacturing processes/Bill of Materials/Material requirements and to develop associated workflows.
  • Effective oral and written communication skills
  • Ability to comprehend basic principles of engineering, physiology and medical device use
  • Ability to solve problems of moderate scope and complexity.
  • Knowledge of ISO13485, CFDA and FDA requirements (21CFR Part820 and FDA 21 CFR Part 11) will be added advantage


To apply, please visit to www.gmprecruit.com and search for Job Reference: 18935

To find out more about this opportunity, please contact Alexandra at: alexandra@gmprecruit.com

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: R1101491

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