Senior QMS Engineer – Audit & Compliance Leader

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

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.