About the Company
We are looking for an experienced QMS Supervisor to strengthen our Quality Management team in ensuring the implementation, maintenance, and continuous improvement of the Quality Management System in accordance with national and international standards.
About the Role
Key Responsibilities
Ensure the implementation and improvement of the QMS in compliance with ISO 13485, ISO 9001, IATF 16949, 21 CFR 820, HALAL Assurance System, CPB, and ISO 17025.Coordinate internal and external audits, including effective follow-up of CAPA.Manage quality documentation: procedures, SOPs, Work Instructions, DHR, DMR, and change control processes.Coordinate plant certifications (ISO, CPB, HALAL) and product certifications (HALAL, TKDN).Support product registration according to the regulatory requirements of destination countries and customer requirements.Monitor and update quality policies, Halal policies, and company quality objectives.Assisting and coordinating department event and projects with relevant departments (RCC, Awareness Campaign & Quality System development).
Qualifications
Bachelor’s degree in Industrial Engineering, Biomedical Engineering, Pharmacy, or related field.Experience in QA/QMS within the medical device, pharmaceutical, or automotive industry, with hands-on involvement in implementing the following standards: ISO 13485 (preferably >5 years), ISO 9001 (preferably >5 years), IATF 16949 (preferably >3 years), HALAL Assurance System (preferably >3 years), and ISO 17025 (preferably >1 year).Proficient in active English skills.Assertive, detail-oriented, innovative, proactive, communicative.
Required Skills
Microsoft Apps (Outlook, Offices, Teams)Quality Systems, QC Seven Tools & Six Sigma is preferredRisk Management & Project ManagementDocument Management
