• Global Medical Devices MNC
• Working Location: East

Responsibilities:

• 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.

Requirements:

• 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