HOD NPI Engineering

• Taking the necessary action to ensure that the standards related to ISO 13485 GMP product ISO standards and other regulatory requirements are achieved at all times.
  

• Technical Support to manufacturing and technical sales
  
• New material investigation & evaluation
  
• New customer technical support
  
• Manufacturing process development
  
• Validation and revalidation activities
  
• Process verification activities
  

• Initiate Validation Master Plan for new projects
  
• Develop manufacturing process for new projects
  
• Provide technical support to other departments in product quality manufacturing concerns and customer complaints
  
• Generate project proposals in conjunction with customers and the marketing department.
  
• Ensure that the manufacturing process of all products is developed in a controlled manner and adhere to existing regulatory requirements.
  
• Produce regular progress reports on assigned projects.
  
• Control the transfer of the manufacturing process of new products to production.
  
• Develop new process and modify existing production process as identified by the Top Management.
  
• Evaluate competitor products when applicable to new development and keep up to date with current changes in technology.
  
• Ensures that trials/validation programs that involve engineering are completed on a cost effective and timely basis.
  
• Review and evaluate change requests from supplier and customer.
  
• Authorized to stop production if equipment and/or process used in production not in state of validated
  
• Authorized to approve new process parameter for production operation
  
• Authorized to approve new tool/mold/die/jig to be utilized in the production
  
• Authorized to approve new components/materials to be used in the production
  
• Carry out/manage any other projects or tasks as requested by the Managing Director and/or Technical/NPI Director from time to time.
  

Requirements

• Candidate must possess at least a college Degree in Engineering / Science & Technology or equivalent with a thorough working knowledge of High Tech / Engineering principles essential.
  
• At least three (3) years experience in project management / research & development preferably with experience in moulding assembly and automation process.
  
• Preferably with working experience in a manufacturing environment that is ISO 13485 certified.
  
• Preferably with knowledge of ISO 13485 FDA 21 CFR Part 820 and GMP.
  
• Initiative creativity resourcefulness and ability to work independently are essential.
  
• Good written and spoken English and Bahasa Melayu.
  
• Computer literate.