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Munivac Sdn Bhd invites a Quality professional to support the Quality Manager in establishing and maintaining a robust QMS across the organization. You will monitor product quality, conduct audits, drive CAPA and continuous improvement, and liaise with suppliers and customers.
The role requires a Diploma or Degree in Engineering or Quality Management with 1–3 years in QA/QMS environments, preferably in medical devices or regulated industries.
Support the Quality Manager to establish and maintain an effective quality management system and processes in compliance to various quality management system standards, meeting customers as well as relevant statutory and medical device regulatory requirements.
Maintain and improve Quality Management Systems.
Monitor product and process quality to ensure compliance with specifications and customer requirements.
Conduct internal audits and support external audits by customers, certification bodies, and regulatory agencies.
Lead investigations, root cause analysis, corrective actions, preventive actions (CAPA), and continuous improvement activities.
Review quality data, identify trends, and recommend improvement actions.
Handle customer complaints and quality-related issues, including preparation of 8D/PDCA reports.
Liaise with suppliers, customers, and internal teams on quality matters.
Control non-conforming products and support containment activities when quality issues arise.
Maintain quality documentation, records, procedures, work instructions, and training programs.
Support QC Inspectors and Technicians in inspection and quality-related activities.
Diploma or Degree in Engineering, Quality Management, or related technical discipline.
Minimum 1-3 years of experience in Quality Assurance, Quality Control, or Quality Management System functions.
Experience in medical devices, manufacturing, or regulated industries is advantage.
Familiar with relevant standards and regulations (e.g., ISO 9001, IATF 16949, ISO 13485, GMP).
Strong problem-solving, analytical, and root cause analysis skills.
Good written communication and interpersonal skills.
Manufacturing, Transport & Logistics 101-1,000 employees
Munivac Sdn Bhd was established in year 1999, specialising in the manufacturing of highly precision engineering components; from complex tooling to precision sub-assemblies manufacturing. Munivac serves a wide spectrum of top global OEMs from varied industries, medical and healthcare, food and beverage, and personal care industries.