Boston Scientific Quality Eng 

Malaysia, Penang 

594988137

Purpose Statement

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

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.

Job Requirements:

• Candidate required process at least Bachelor Degree in Science/ Engineering.
• Prefer candidate with 1-3 years working experience in quality engineering, medical device/ pharmaceutical manufacturing experience will be added advantage. Fresh graduates are encouraged to apply.