QMS Engineer

A. PURPOSE OF THIS POSITION:

We are seeking a QMS Engineer for the Operations department at our state-of-the-art world class electronics manufacturing located in Nam Tan Uyen Industrial Park. As this position, you will play a critical role in ensuring the effective implementation and maintenance of the Quality Management System (QMS) within our organization. You will collaborate with cross-functional teams to develop, improve, and monitor quality processes, procedures, and policies. Your expertise will contribute to maintaining compliance with regulatory standards, promoting continuous improvement, and achieving organizational quality objectives. 

B. PRIMARY RESPONSIBILITIES:

1. Develop and Maintain QMS:

- Develop, maintain and improve QMS set up the standard operation procedure, work instruction and its operation processes complies to the QMS standards (ISO9001, AS9100, ISO13485).

- Coordinate the related functions to set up QMS objectives, action plan and lead the implementation to support the organization’s goals.

- Enhance QMS effectiveness thru the monitoring and measuring its operations and continuous improvement initiative. Report, handle and monitor the system nonconformity to ensure the corrective and preventive action taking effectively.

- Organize and lead the internal quality audit programs to monitor and measure the conformity and effectiveness of the QMS. Initiate necessary continuous improvement activities including root cause corrective action and preventive action.

2. Special Requirements for this position:

- To assure the QMS system is implemented under controlled condition; always work toward high quality 

3. Compliance and Auditing:

- Conduct regular internal audits of processes, procedures, and documentation to ensure compliance with quality standards, industrial standards, regulatory, corporate and customer requirements.

- Organize ISO audits, NADCAP audits, Customer audits, Compliance audits (UL, ETL, SIQ...) and FDA audits.

- Collaborate with internal stakeholders to address audit findings, implement corrective actions, and monitor their effectiveness.

- Stay updated with regulatory & standard changes and industry best practices to ensure ongoing compliance.

4. Process Improvement:

- Identify opportunities for process improvement within the QMS framework and drive initiatives to enhance operational efficiency and effectiveness.

- Analyze quality data and metrics to identify trends, issues, and improvement opportunities, and recommend corrective and preventive actions.

- Facilitate and lead cross-functional teams in process improvement projects, applying quality tools and methodologies (Six Sigma, Lean).

5. Training and Awareness:

- Develop and deliver training programs on quality procedures, processes, and tools to increase awareness and ensure consistent implementation throughout the organization.

- Collaborate with HR and relevant departments to identify training needs and provide guidance on quality-related training and development initiatives.

6. Others: Assigned by superior.

1. Education: 

- Bachelor’s degree in Engineering or a related field, or equivalent working experience of QMS. Six Sigma Green Belt / Black Belt Certification is a plus.

- Lead Auditor of ISO14001, ISO9001, AS 9100 or ISO13485 is prefer.

2. Experience: 

- Proven experience (4+ years) in electronics manufacturing, strong knowledge of quality standards and regulations (ISO 9001, AS9100, ISO 13485, ISO14001, NADCAP, FDA regulations) and their practical application.

3. Others: 

- Fluent in written and verbal English.

- Experience in developing, implementing, and maintaining a QMS, including documentation control and process mapping.

- Proficiency in quality tools and methodologies (e.g., statistical analysis, root cause analysis, process improvement).

- Excellent analytical skills with the ability to collect, analyze, and interpret quality data and metrics.

- Ability to work with ISO/AS/IPC standards.

- Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and stakeholders at all levels.

- Detail-oriented with a commitment to accuracy and a high level of integrity.

- Ability to manage multiple priorities, work independently, and drive projects to completion.