Quality Engineer

7 days ago

Greater Kuala Lumpur, Malaysia Boston Scientific Full time

Key Responsibilities

  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
  • Ensure Quality engineering methodologies systems practices which meets BSC, customer and regulatory requirements.
  • Create, and revise, departmental procedures.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Develop testing and inspection methodologies and documentation for new and existing products. Generate test protocols/reports and execute qualification and validation testing.
  • Responsible for reviewing and developing validation protocols and reports. Support other functional areas during the validation activities
  • Interface with other engineering departments within the company, customers, and suppliers on quality related issues.
  • Conversant with validation techniques and associated regulatory requirements

Requirements

  • Minimum Degree in Engineering or Science
  • At least 5 years of experience in Operations Quality. Prior experience in the medical device industry is preferred.
  • Required skills: Resolves issues using standard problem-solving tools and a strong understanding of quality operations fundamentals, including product risk assessment and data analysis to identify root causes and drive solutions. Communicates findings clearly and effectively. Process validation.
  • Experience in product transfer will be added advantage.

Requisition ID:
604223

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