QMS Executive (Mandarin Speaker)

Kobay Technology Berhad; Penang; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading technology company in Malaysia is seeking a Quality Management professional to implement and improve QMS processes, conduct internal audits, and ensure compliance with industry standards. You will lead investigations into non-conformities, manage CAPA implementation, and train staff on compliance protocols. Strong experience with ISO standards and compliance is required.

Qualifications

• Experience with quality management systems like ISO 9001 and ISO 13485.
• Strong knowledge of compliance protocols and standards.
• Ability to conduct training sessions and promote compliance culture.

Responsibilities

• Implement and improve QMS processes in line with industry standards.
• Conduct internal audits and identify compliance gaps.
• Lead investigations of non-conformities and implement CAPA plans.
• Train manufacturing staff on compliance protocols.

Job description

Quality Management System (QMS):

• Implement, maintain, and improve QMS processes and procedures in line with industry standards (e.g., ISO 9001, ISO 13485, etc.).
• Ensure manufacturing activities comply with all relevant internal policies and external regulatory requirements.

Internal Audits & Risk Assessments:

• Conduct regular internal audits and compliance assessments of manufacturing operations.
• Identify process risks, gaps, or deviations and initiate appropriate corrective measures.

Non-Compliance Management:

• Lead root cause analysis and investigations of non-conformities, deviations, and product quality issues.
• Collaborate with cross-functional teams to implement effective corrective and preventive actions (CAPA).

CAPA Implementation:

• Develop, execute, and monitor CAPA plans to ensure timely and sustainable resolution of compliance issues.
• Track effectiveness of actions taken and ensure closure within defined timelines.

Training & Awareness:

• Conduct training sessions for manufacturing staff on compliance protocols, standards, and best practices.
• Promote a culture of quality and compliance across the organization.

Subject Matter Expert:

• Serve as a key resource for compliance-related inquiries, audits, and improvement initiatives.
• Support external and customer audits by providing necessary documentation and process walkthroughs.
• Any ad hoc tasks assigned by management or company.