Quality Engineer

TipTopJob.com Malaysia; Seberang Perai; On-site; MYR 40,000 - 80,000; Full time

Job summary

An established industry player in medical technology seeks a dedicated Quality Engineer to enhance product quality and compliance. In this pivotal role, you will develop and implement quality engineering methodologies that align with regulatory standards and customer expectations. Collaborating with cross-functional teams, you will identify and resolve quality issues efficiently, ensuring that products meet the highest quality benchmarks. If you are passionate about improving patient health through innovative solutions and thrive in a dynamic environment, this opportunity is perfect for you.

Qualifications

• Erfahrung in der Entwicklung und Implementierung von Qualitätsmethoden.
• Kenntnisse in regulatorischen Anforderungen und Validierungsprozessen.

Responsibilities

• Implementierung von Prozesskontrollsystemen zur Unterstützung der Produktentwicklung.
• Entwicklung von Test- und Inspektionsmethoden für neue Produkte.

Skills

Qualitätsengineering

Prozesskontrollsysteme

Problemlösungsmethodiken

Validierungstechniken

Education

Bachelor in Ingenieurwesen

Zertifizierung in Qualitätsmanagement

Tools

Qualitätsmanagementsoftware

Testprotokoll-Software

Job description

Purpose Statement
Develops, establishes, and maintains quality engineering methodologies, systems, and practices that meet BSC, customer, and regulatory requirements. Serves as a Quality representative to enhance awareness, visibility, and communication on quality initiatives supporting 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 over 40 years, Boston Scientific (NYSE: BSX) aims to transform lives through innovative medical solutions that improve patient health. If you're looking to make a meaningful difference globally and locally, this is the place to do it.

Key Responsibilities

1. Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing to meet or exceed requirements.
2. Ensure quality engineering methodologies, systems, and practices meet BSC, customer, and regulatory standards.
3. Create and revise departmental procedures.
4. Support quality disciplines, decisions, and practices as an effective leader or team member.
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 efficiently.
7. Develop testing and inspection methodologies and documentation for new and existing products, including test protocols and reports, and execute qualification and validation testing.
8. Review and develop validation protocols and reports; support other functional areas during validation activities.
9. Collaborate with engineering departments, customers, and suppliers on quality-related issues.
10. Maintain knowledge of validation techniques and regulatory requirements.

Requisition ID: 604223