- Johor Bahru Johor Malaysia
Full Time Quality Assurance - Quality Control Manager Jobs, in NPAworldwide Johor - Maukerja
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Responsibilities
Job Description
- Based on KS-P17 Inspection and Testing Process & Status Procedure, Inspection Plan, Product Specification and Work Instruction to set up quality inspection system (IQC, IPQC and OQC).
- Review and communicate with production section about final and final inspection results and defect issue via memo, sample defect, inspection report, issued PCAR or Microsoft Teams group.
- Review the PCAR closed with effectiveness.
- Review the summary NR and/or Nimble AQL 1.5 and above % summary for NR and/or analysis on trend of critical defect to see whether achieve company quality objective, quality goals and departmental objective which relate to quality field and submit those report to Executive Director for the month of January each year.
- Orientated quality staff to fulfill both customer and factory quality specifications.
- Motivate all the QA/QC team working spirit and make sure the team implements ISO system with fluency and continuously through the training program.
- Evaluate the subordinate job performance.
- Present the production line performance during production meeting and send monthly production process quality to customer-Cardinal (If Factory 3 have planning to run Cardinal product).
- Handling customer complaint based on KS-P24 Customer Complaint/Medical Device Reporting, KS-P20 Corrective and Preventive Action and KS-P19 Control of Non-Conforming Product procedure.
- To demonstrate the mock recall based on KS-P35 Recall procedure.
- Discuss with Executive Director about quality plan which need to revise and make the quality system more efficient and effective.
- To carry out the job which assigned by Executive Director.
- Multiple task as an internal auditor to conduct internal audit.
- Compile DHR file, etc.
- Manage both plant KS and KSG.
- Review and analyze weekly AI inspection results, including failed rejects and successful rejects, to identify trends and opportunities for process improvement. (Applicable to KSG.)
- Oversee AI inspection system performance and coordinate with the Reebow team regarding system performance, issues, troubleshooting, and improvement activities. (Applicable to KSG).
- Lead investigation and corrective actions for any significant quality issues or abnormal trends identified through AI inspection data and quality monitoring activities. (Applicable to KSG).
- Preferable Degree or above in related field.
- Strong working experience in the related field.
- Good interpersonal skill, able to read & write Bahasa Malaysia, English.
- Able to motivate others and work independently.
- Strong analytical skills & communication skills.
- Strong managerial, supervisory, and leadership skills are essential.
- Experience in an ISO 13485 or ISO 22000 quality/food safety management system.
- Knowledge of quality control.
- Comprehensive Quality Management Exposure Offers responsibility for establishing and overseeing IQC, IPQC, and OQC systems, ensuring product quality and consistency across manufacturing processes.
- Leadership and Team Development Provides opportunities to lead QA/QC teams, evaluate staff performance, deliver training, and strengthen quality awareness across the organisation.
- Medical Device Quality and Compliance Expertise Builds specialised knowledge in ISO 13485, internal auditing, corrective and preventive actions (CAPA), customer complaints, and regulatory compliance procedures.
- Advanced Quality Analysis and Process Improvement Offers exposure to AI inspection systems, defect trend analysis, root cause investigations, and continuous improvement initiatives to enhance manufacturing quality.
- Strategic Decision-Making and Multi-Plant Management Involves overseeing quality operations across two plants, reporting quality performance to senior management, and collaborating with production teams and external stakeholders to improve overall operational efficiency.
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