Senior QMS Engineer

INTRETECH (MALAYSIA) SDN. BHD. 盈趣科技（马来西亚）有限公司; Kulai; On-site; MYR 78,000 - 112,000; Full time

Job summary

Intretech (Malaysia) Sdn. Bhd., a subsidiary of Intretech Inc. (Xiamen, China), specialises in assembly of electrical and electronic products and SMT processes for clients in the U.S. and Europe. The company also capabilities in medical device manufacturing and delivers end-to-end solutions from R&D to mass production.

Join us to shape the future of intelligent manufacturing with a strong focus on quality management systems and regulatory compliance across ISO and FDA standards.

Qualifications

• At least 5 years experience in this field.
• Mandarin speaking will be added advantage.
• Experience in organizing and leading internal or external audit.
• Knowledge in ISO 9001, ISO 14001, IATF 16949, ISO 27001, ISO 13485, FDA, GMP, etc.

Responsibilities

• Ensure quality objectives fit the strategic direction.
• Integrate QMS requirements into the organization's business processes.
• Communicate the importance of QMS requirements.
• Engage, direct and support people to participate in the QMS.
• Ensure customer and legal requirements are met.
• Identify and address risks and opportunities.
• Assign responsibility for the QMS, its processes, reporting, and managing change.
• Lead on internal and external audits.

Job description

ensure quality objectives fit the strategic direction

ensure QMS requirements are integrated into the organization's business processes

communicating the importance of the QMS requirements

engaging, directing and supporting people to participate in the QMS

ensure customer and legal requirements are met

ensure that risks and opportunities are identified and addressed

assign responsibility for the QMS, its processes, reporting, and for managing change

lead on internal and external relevant audits

performs all company business in accordance with all regulation and company policy and procedures

Job Requirements:

• At least 5 years experience in this field
• Honestly, responsible, open minded, candid, and high personal integrity
• Experience in organizing and leading internal or external audit
• Knowledge in ISO 9001, ISO 14001, IATF 16949, ISO 27001, ISO 13485, FDA, GMP, etc.
• Mandarin speaking will be added advantage, since need to communicate with HQ at China and also some China customer or supplier.

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• How many years' experience do you have as a Quality Management System Engineer?
• Which of the following types of qualifications do you have?
• Have you worked in a role which requires a sound understanding of IATF 16949?

Intretech (Malaysia) Sdn. Bhd., established in 2016, is a subsidiary of Intretech Inc. (Xiamen, China), a global leader in smart manufacturing. We specialize in the assembly of electrical and electronic products, including SMT processes, and serve as a trusted contract manufacturer for clients in the U.S. and Europe.

Our capabilities also extend to medical device manufacturing. Backed by our unique UDM model, advanced technology, and quality systems, we deliver end-to-end solutions from R&D to mass production. “Intretech – Make Life Interesting” reflects our mission to innovate, inspire, and connect with the world.

Join us to shape the future of intelligent manufacturing.

Intretech (Malaysia) Sdn. Bhd., established in 2016, is a subsidiary of Intretech Inc. (Xiamen, China), a global leader in smart manufacturing. We specialize in the assembly of electrical and electronic products, including SMT processes, and serve as a trusted contract manufacturer for clients in the U.S. and Europe.

Our capabilities also extend to medical device manufacturing. Backed by our unique UDM model, advanced technology, and quality systems, we deliver end-to-end solutions from R&D to mass production. “Intretech – Make Life Interesting” reflects our mission to innovate, inspire, and connect with the world.

Join us to shape the future of intelligent manufacturing.