Quality Engineer

• 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

• 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.

Boston Scientific