Quality Engineer

Boston Scientific Gruppe; Batu Kawan; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading medical technology company is seeking a Quality Engineer to develop and maintain quality engineering systems and practices. The role involves ensuring compliance with regulatory requirements and improving communication on quality initiatives across various functions. The ideal candidate will possess strong problem-solving skills and the ability to interface with various engineering departments.

Qualifications

• Conversant with validation techniques and regulatory requirements.

Responsibilities

• Identify and implement effective process control systems.
• Develop testing and inspection methodologies and documentation.
• Act as a leader or team member in supporting quality disciplines.

Job description

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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.

About Us
As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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.

Requisition ID:604223

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