Quality engineer [medical device] - Bukit Mertajam

• Reporting to: Senior Quality Manager
• Based in Penang
• Attractive remuneration and benefits package

• Develop and oversee process control systems that support product development, qualification, and manufacturing, ensuring compliance with both internal standards and external regulatory requirements.
• Ensure quality systems and engineering practices consistently meet the expectations of BSC, customers, and regulatory bodies.
• Create and maintain quality-related procedures to support departmental objectives and drive continuous process improvement.
• Lead or contribute to cross-functional teams, providing expertise in quality systems and supporting informed, compliant decision-making.
• Apply structured problem-solving approaches to effectively identify, analyze, and resolve quality issues in a timely manner.
• Support the development of efficient business processes that enhance quality issue detection, communication, and resolution.
• Design and execute validation and test protocols, including documentation for product inspections, qualifications, and regulatory submissions.
• Foster a culture of quality and compliance, ensuring alignment with company policies and regulatory requirements, while maintaining focus on patient safety and product integrity.

• Bachelor’s degree or higher in Engineering, Science, or a related field is required.
• 3 to 7 years of experience in Quality Engineering, Quality Control, or Quality Operations within a multinational company (MNC); experience in the medical device industry is a strong advantage.
• Demonstrates a positive, proactive attitude with a willingness to take on challenges and strong leadership potential, including excellent communication and interpersonal skills.
• Project management or project transfer experience is an added benefit.
• skills

• qualifications

• education

Bachelor Degree

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