Engineer, Quality System

Masimo; Pasir Gudang; On-site; MYR 60,000 - 100,000; Full time

Job summary

An established industry player is looking for a dedicated Quality System Engineer to enhance product quality and drive continuous improvement. In this pivotal role, you will develop and maintain quality management systems, ensuring compliance with industry standards such as ISO 9001 and ISO 13485. You will collaborate with cross-functional teams, conduct audits, and implement process improvements. This position offers the opportunity to make a significant impact on product quality and organizational efficiency while working in a dynamic office and production environment. If you are passionate about quality management and eager to contribute to a forward-thinking team, this role is perfect for you.

Qualifications

• 5+ years of experience in quality management or a similar role.
• Knowledge of relevant quality standards and regulations.

Responsibilities

• Develop and maintain an effective Quality Management System.
• Conduct internal and external audits to assess compliance.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Interpersonal Skills

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Quality Management

Tools

Quality Management System (QMS)

ISO 9001

ISO 13485

Job description

Job Summary:

We are seeking a highly skilled and motivated Quality System Engineer to join our team. The ideal candidate will be responsible for developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulations. The Quality System Engineer will play a key role in enhancing product quality, improving processes, and driving continuous improvement initiatives.

Duties & Responsibilities:

1. Quality Management System (QMS) Development:
   • Develop, implement, and maintain an effective Quality Management System in compliance with relevant industry standards (e.g ISO 9001, ISO 13485).
2. Regulatory Compliance:
   • Ensure that the organization complies with all relevant quality and regulatory standards.
   • Stay informed about changes in regulations and standards affecting the industry and implement necessary updates to the QMS.
3. Process Improvement:
   • Identify opportunities for process improvements and work collaboratively with cross-functional teams to implement changes.
   • Conduct root cause analysis and implement corrective and preventive actions.
4. Documentation Management:
   • Oversee the creation, revision, and maintenance of quality documentation, including procedures, work instructions, and records.
5. Audits and Inspections:
   • Plan and conduct internal and external audits to assess compliance with quality standards.
   • Prepare for and support regulatory inspections as needed.
6. Training:
   • Develop and deliver training programs on quality management principles and practices.
   • Ensure that employees are trained on relevant quality procedures and standards.
7. Risk Management:
   • Implement and maintain a risk management process to identify and mitigate potential risks to product quality.
8. Supplier Quality Management:
   • Collaborate with suppliers to ensure the quality of incoming materials and components.
   • Conduct supplier audits and assessments as needed.
9. Metrics and Reporting:
   • Establish key performance indicators (KPIs) and regularly report on the performance of the Quality Management System.
   • Use data-driven insights to make informed decisions and drive continuous improvement.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:
• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum 5 years of experience in quality management or a similar role.
• Knowledge of relevant quality standards and regulations.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Certification in quality management (e.g., ASQ Certified Quality Engineer) is a plus.

Preferred Qualifications:
• Not applicable

Education:
Bachelor’s degree or equivalent.

Physical requirements/Work Environment:
This position primarily works in an office and manufacturing/production environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.