Quality Engineer

Boston Scientific; Kampung Sekolah Simpang Ampat; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading company in the medical devices industry is seeking a Quality Engineer to maintain quality engineering methodologies and systems. In this role, you will lead initiatives to ensure compliance with customer and regulatory requirements, aiming for excellence in product quality.

Qualifications

• 3-7 years of experience in Quality Engineering or Quality Control.
• Experience in medical devices is an advantage.
• Project management experience is a plus.

Responsibilities

• Identify and implement effective process control systems for product development.
• Review and develop validation protocols and reports.
• Create and revise departmental procedures.

Skills

Process Control

Problem Solving

Quality Assurance

Leadership

Communication

Education

Bachelor's degree in Engineering or Science

Job description

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

Job Responsibilities:

1. Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
2. Ensure quality engineering methodologies, systems, and practices meet BSC, customer, and regulatory requirements.
3. Create and revise departmental procedures.
4. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
5. Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
6. Develop and execute streamlined business systems to identify and resolve quality issues.
7. Develop testing and inspection methodologies, create documentation, and generate test protocols/reports for new and existing products, including qualification and validation testing.
8. Review and develop validation protocols and reports. Support other functional areas during validation activities.
9. Interface with engineering departments, customers, and suppliers on quality issues.
10. Be familiar with validation techniques and regulatory requirements.
11. Demonstrate commitment to patient safety and product quality, maintaining compliance with quality policies and procedures.

If supervising, ensure resources are maintained for quality system compliance, and promote a work environment supporting the Quality Policy and System.

Job Requirements:

• Bachelor's degree in Engineering, Science, or related field.
• 3-7 years of experience in Quality Engineering, Quality Control, or Quality Operations from MNCs.
• Positive attitude, winning spirit, and proactive behavior.
• Potential for leadership; good communication and articulation skills.
• Experience in medical devices is an advantage.
• Experience in project management or project transfer is an advantage.
• Willing to travel to Batu Kawan, Penang.