The QC Inspector is responsible for performing quality inspections and testing across incoming materials, in-process production, and finished goods to ensure products meet Medisafe Technologies' quality standards, regulatory requirements, and customer specifications. The role requires frequent travel to supplier, production, and customer sites to conduct on-site inspections and audits, and works closely with Production, Engineering, and Suppliers to manage defects, maintain quality documentation, monitor processes, and drive continuous improvement.
Key Responsibilities
1. Inspections & Testing
- Conduct incoming, in-process, and outgoing quality inspections on raw materials, components, and finished products against approved specifications, drawings, and SOPs.
- Perform dimensional, visual, and functional testing using standard QC tools and equipment (e.g. calipers, gauges, multimeters, test rigs).
- Travel frequently to supplier/vendor sites, production facilities, and customer sites to carry out on-site inspections, source inspections, and acceptance testing.
- Verify product and process compliance with applicable regulatory standards (e.g. ISO 13485, GMP) and customer requirements.
2. Defect Management
- Identify, record, and report non-conformances and defects found during inspection using the company's NCR (Non-Conformance Report) system.
- Segregate and control non-conforming materials/products to prevent unintended use or shipment.
- Initiate, track, and follow up on Corrective and Preventive Actions (CAPA) for critical or recurring defects.
- Work with Production, Engineering, and Suppliers to investigate root causes and verify effectiveness of corrective actions.
3. Documentation
- Complete and maintain accurate inspection records, checklists, and test reports for every inspection performed.
- Prepare and update quality documents including inspection plans, work instructions, and SOPs.
- Ensure full traceability of inspection results, NCRs, and CAPA records within the Quality Management System (QMS).
- Keep all quality documentation audit-ready at all times to support internal and external audits.
4. Process Monitoring
- Monitor ongoing production processes for compliance with quality standards, work instructions, and specifications.
- Conduct in-process quality checks and spot checks along the production line.
- Track quality data and trends, and flag process deviations for timely escalation and action.
- Support First Article Inspection (FAI), process validation, and qualification activities.
5. Continuous Improvement
- Participate in root cause analysis and problem-solving activities (e.g. 5-Why, Fishbone, 8D) for quality issues.
- Propose and support the implementation of corrective and preventive measures to reduce defect and rejection rates.
- Contribute to Lean/Kaizen initiatives aimed at improving inspection efficiency and overall product quality.
- Provide guidance and on-the-job feedback to production staff on quality standards and inspection criteria.
Requirements
- Diploma/Degree in Engineering, Science, Quality Management, or a related field.
- 1-3 years of relevant experience in Quality Control/Quality Assurance within a manufacturing environment; experience in medical device or regulated industries is an advantage.
- Working knowledge of ISO 13485, ISO 9001, GMP, or other applicable quality/regulatory standards.
- Proficient in the use of standard inspection tools and measuring equipment.
- Willing and able to travel frequently, including to supplier, production, and customer sites (local and/or overseas).
- Possess own transport and a valid driving license (where required for site travel).
- Meticulous, detail-oriented, with good documentation and record-keeping discipline.
- Good communication and coordination skills to work with cross-functional teams and external parties.
Pay: RM1,800.00 - RM2,500.00 per month
Benefits:
- Additional leave
- Cell phone reimbursement
- Free parking
- Maternity leave
- Opportunities for promotion
- Professional development
Work Location: In person