Regulatory & Quality Manager
Job Summary
The Regulatory Affairs & Quality Manager leads government licensing applications and ensures compliance with MIDA and SIRIM standards. The role involves managing daily QA/QC operations and maintaining the company's Quality Management System (QMS). It requires a Malaysian citizen with significant experience in manufacturing regulatory and quality management.
Responsibilities
- Manage MIDA licensing and compliance
- Lead SIRIM certification processes
- Oversee QA/QC operations and QMS
- Execute root-cause analysis and corrective actions
Required Skills
- MIDA & MITI regulatory knowledge
- SIRIM certification management
- QA/QC manufacturing experience
- ISO/GMP/HACCP compliance
- Fluent in English and Bahasa Malaysia
Job Details
Government Liaison & Licensing (MIDA & MITI)
- License Application: Lead the end-to-end application and renewal of the MIDA Manufacturing License under the Industrial Coordination Act 1975.
- Compliance Monitoring: Ensure the company fulfills all MIDA compliance conditions, including the 80% local workforce ratio and the 25% Managerial, Technical, and Supervisory (MTS) staff threshold.
- Tax & Duty Exemptions: Prepare documentation and apply for MIDA tax incentives (e.g., Pioneer Status) and import duty/sales tax exemptions for machinery and raw materials.
Product & Industrial Certification (SIRIM)
- Product Certification: Manage the full application process for SIRIM Product Certification Schemes and ensure products comply with Malaysian Standards (MS) or international standards.
- Audit Readiness: Act as the primary window for SIRIM QAS International during factory audits, technical document evaluations, and sample testing procedures.
- Labeling & Marks: Oversee the proper deployment and tracking of SIRIM labels and security marks on finished goods.
Quality Management System (QMS) Routine Operations
- Daily QA/QC Operations: Oversee all quality assurance and quality control testing, inspection workflows, and laboratory operations from incoming raw materials to final product dispatch.
- System Maintenance: Establish, implement, and maintain routine operation of the company's QMS (e.g., ISO 9001, GMP, or HACCP).
- Continuous Improvement: Lead root-cause analysis for any quality failures, manage non-conformance reports (NCR), and execute corrective actions.
Requirements
- Nationality: Malaysian Citizen only.
- Education: Bachelor’s Degree in Engineering, Sciences, Quality Management, or a related technical discipline.
- Experience: Minimum 5–8 years of experience in QA/QC within a manufacturing environment, with at least 3 years in a managerial role.
- Specific Skills: Proven track record of successfully securing MIDA Manufacturing Licenses and handling SIRIM certifications. Deep understanding of local statutory requirements, Department of Environment (DOE) guidelines, and MITI regulations. Strong communication skills in English and Bahasa Malaysia.