Quality Management System (QMS) Engineer
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- QMS Implementation and Maintenance: lead the development, implementation, and maintenance of the company’s QMS in compliance with relevant industry standards (e.g. ISO 9001, IATF 16949, ISO 14001, OHSAS).
- Auditing and Compliance: Plan, conduct, and manage internal and external audits to ensure compliance with QMS requirements, industry regulations and customer standards. Support third-party audits and certifications.
- Document Control: Establish and maintain document control processes, ensuring all quality-related documentation is accurate, up-to-date, and easily accessible.
- Process Improvement: Identify opportunity for process improvement within the QMS and manufacturing processes. Work with relevant departments to implement changes that enhance efficiency and quality.
- CAPA Management: Lead corrective and preventive actions (CAPA) programs to address non-conformances, ensuring timely resolution and documentation of root causes, corrective actions, and preventive measures.
- Training and Education: Develop and deliver training programs to employees on quality management system processes, regulatory requirements, and industry best practices to ensure compliance and awareness.
- Risk Management: Support risk management activities, including Failure Modes and Effects Analysis (FMEA) and other tools, to pro-actively address potential quality risks in process and products.
- Data Analysis and Reporting: Analyse quality data, trends, and key performance indicators (KPIs) to report on the health of the QMS. Provide management with actionable insights to drive continuous improvement.
- Regulatory Compliance: Stay up-to-date with changes in industry standards, regulations, and best practices. Ensure the company is compliant with current and future regulatory requirements.
- Develop and implement calibration procedures and techniques.
- Use precision measurement devices to calibrate, inspect, and test equipment to ensure that it meets specifications.
- Identify and rectify problems associated with equipment calibration and performance.
- Coordinate with other engineers and technicians to ensure the implementation of correct calibration methods.
- Maintain calibration records and certifications for audit purposes.
- Recommend and implement improvements for calibration procedures and methods.
- Train and assist other technicians in calibration techniques.
- Order, maintain, and manage calibration equipment and tools.
- Ensure that all calibration activities adhere to quality standards and regulations.
- Perform routine maintenance on equipment and systems to prevent malfunctions.
Job Requirements:
- Bachelor’s Degree in Engineering (Industrial, Mechanical, Electrical, or related field)or Quality Management.
- Minimum of 3-5 years of experience in quality management system roles, preferably in manufacturing, automotive, medical devices, or a relate field.
- Certification in Quality Management (e.g. Certified Quality Engineer - CQE, or Six Sigma Green Belt is preferred.
- Familiarity with QMS standards such as ISO9001, ISO14001, IATF16949, and experience with other relevant regulations.
- Strong background in leading and participating in internal and external audits (ISO, regulatory, and customer audits).
- Hands-on experience with Quality Management Systems (QMS) and quality assurance methodologies.
- In-depth understanding of technical documentation.
- Solid understanding of calibration techniques and equipment.
- Proficient in using calibration software and hardware.
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How many years' experience do you have as a Quality Management System Engineer? Which of the following statements best describes your right to work in Malaysia? What's your expected monthly basic salary? Which of the following types of qualifications do you have? How many years' experience do you have as a Quality Management Engineer? How many years of auditing experience do you have? Which of the following languages are you fluent in? How much notice are you required to give your current employer?
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