Senior Quality Engineer – Validation & Compliance

Boston Scientific Corporation; Penang; Presencial; MYR 80.000 - 110.000; Jornada completa

Descripción de la vacante

Boston Scientific Corporation in Malaysia is seeking a Quality Engineer to support quality initiatives across development, manufacturing and quality systems. You will apply validated methods to ensure compliance with customer and regulatory requirements and drive continuous improvement.

You will lead problem-solving activities, develop procedures, and collaborate with engineering, suppliers, and cross-functional teams to ensure product safety and quality.

Formación

• Bachelor's degree in Engineering, Science or related field.
• At least 5 years of working experience in Quality environment.
• Required skills: project management; validation; problem solving; communication; people management.

Responsabilidades

• Identify and implement effective process control systems to support development, qualification, and on-going manufacturing of products to meet internal and external requirements.
• Ensure quality engineering methodologies/systems/practices meet BSC, customer and regulatory requirements.
• Create or revise departmental procedures.
• Act 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.
• Develop testing and inspection methodologies and documentation for new and existing products; generate test protocols/reports and execute qualification and validation testing.
• Review and develop validation protocols and reports; support other functional areas during validation activities.
• Interface with other engineering departments, customers, and suppliers on quality related issues.
• Conversant with validation techniques and associated regulatory requirements.

Conocimientos

Project management

Validation

Problem solving

Communication

People management

Educación

Bachelor's degree in Engineering, Science or related field

Descripción del empleo

Boston Scientific Corporation in Malaysia is seeking a Quality Engineer to support quality initiatives across development, manufacturing and quality systems. You will apply validated methods to ensure compliance with customer and regulatory requirements and drive continuous improvement.

You will lead problem-solving activities, develop procedures, and collaborate with engineering, suppliers, and cross-functional teams to ensure product safety and quality.