Quality Manager

Key Responsibilities and Duties

1. Act as QMR – Quality Management Representative for ISO 9001:2015.

2. Develop and Implement Quality Standards:

• Create, update, and enforce quality control policies and procedures.
• Ensure the organization adheres to quality system requirements.

3. Maintaining an effectiveness implementation of ISO 9001: 2015 Quality System within the scope of performing system audits at least once a year:

• Internal Quality Audit.
• Management Review meeting.

4. Monitor DCC update the ISO 9001 document and to ensure all department follow the proper flow.

5. Oversee Quality Assurance and Quality Control Processes:

• Monitor and audit internal processes to maintain quality compliance.
• Supervise inspections, testing, and evaluation of products and processes.

6. Lead the Quality Team

• Manage and train quality assurance personnel.
• Assign responsibilities, conduct performance evaluations, and ensure team effectiveness.

7. Manage Non-Conformance and Corrective Actions:

• Investigate customer complaints and internal non-conformances.
• Lead root cause analysis and implement corrective/preventive actions (CAPA).

8. Manage Non-Conformance and Corrective Actions:

• Investigate customer complaints and internal non-conformances.
• Lead root cause analysis and implement corrective/preventive actions (CAPA).

9. Coordinate with Other Departments:

• Work closely with production, engineering and supply chain teams to resolve quality issues.
• Ensure cross-functional quality initiatives and continuous improvement.

10. Conduct Internal and External Audits:

• Plan and execute internal quality audits.
• Liaise with external auditors, regulatory bodies, and clients during audits.

11. Maintain Documentation and Records:

• Ensure accurate and up-to-date quality documentation and reports.
• Maintain records for inspections, tests, and certifications.

12. Drive Continuous Improvement Initiatives:

• Use tools like Six Sigma, Lean, or Kaizen to improve processes.
• Identify trends and propose improvements in quality performance.

13. Ensure Compliance with Health, Safety, and Environmental Regulations:

• Integrate quality initiatives with safety and environmental standards.

14. Report Quality Performance:

• Develop KPIs and dashboards to monitor quality performance.
• Present quality reports to senior management.

15. Ensure customer requirements are clearly understood and implemented within departmental processes.

Qualification / Knowledge / Skills Requirements

1. Candidate must possess at least Diploma/Advanced/Higher/Graduate Diploma in Engineering  (Mechanical), Engineering (Mechatronic/Electromechanical) or equivalent.

2. Preferably at least 5 years of working experience in injection molding.

3. Strong interpersonal, leadership, and communication skills.

4. Mandarin proficiency is essential as the role will communicate directly with Chinese-speaking clients, suppliers and management. Candidate must be able to speak, read and write Chinese confidently.

5. Capable of conducting root cause analysis and implementing corrective/preventive actions.

6. Able to work in high-pressure environment.

7. Required computer skills.

Authority

1. Authority to Represent the Organization on Quality Matters: Serve as the official liaison between the organization and external parties (e.g., ISO auditors, regulatory  bodies) on quality-related issues.

2. Authority to Implement and Maintain the QMS: Direct and enforce the implementation, maintenance, and continual improvement of the Quality  Management System.

3. Authority to Conduct Management Reviews: Convene and lead management review meetings, presenting data on QMS performance and  recommending improvements.

4. Authority to Communicate with All Departments Access and work with all departments to implement QMS requirements and resolve cross-functional quality issues.

5. Authority to Approve or Reject Products: Final decision-making authority on product release based on quality criteria and compliance with  specifications.

6. Authority to Enforce Quality Standards

• Implement and uphold company quality policies across all departments.
• Require adherence to standard operating procedures (SOPs) and regulatory guidelines.

7. Authority to Lead and Supervise QA Personnel

• Manage hiring, training, and performance of the QA team.
• Assign responsibilities and approve QA staffing decisions.

Working Condition

1. Typically based in an office setting within a manufacturing plant, laboratory, or production facility.

2. Occasional exposure to manufacturing environments with moderate noise, machinery, and  moving equipment (PPE may be required).

3. May require standing or walking for extended periods during inspections or audits.

4. Frequent collaboration with cross-functional teams, including engineering, production, and
   suppliers.

Key Performance Indicators (KPIs)

1. Invidual Attendance & Panctuality

2. Product Quality Metrics:

• First Pass Yield (FPY): Percentage of products passing inspection without rework.
• Defect Rate: Number of defects per batch, unit, or production run.
• Rework and Scrap Rate: Volume of products requiring rework or discarded due to quality issues.

3. Customer Satisfaction and Complaint Handling:

• Customer Complaint Rate: Number of quality-related complaints per month or quarter.
• Complaint Resolution Time: Average time taken to resolve a customer complaint.
• Return Rate (RMA): Percentage of products returned due to quality problems.

4. Audit and Compliance Performance:

• Audit Findings: Number and severity of findings from internal and external audits.
• Audit Closure Time: Time taken to close audit non-conformances or CAPAs.
• Regulatory Compliance Rate: Adherence to standards like ISO 9001

5. Corrective and Preventive Action (CAPA) Effectiveness:

• CAPA Closure Rate: Percentage of corrective actions closed within the due date.
• Recurrence Rate: Frequency of repeated quality issues after CAPA implementation.

6. Process Improvement and Efficiency:

• Process Deviation Rate: Frequency of process deviations or incidents.
• Cycle Time for Quality Approvals: Time to approve production batches, validations, or changes.
• Improvement Projects Completed: Number and impact of quality improvement initiatives led.

7. Team Performance and Training:

• QA Staff Competency Rate: Percentage of staff trained and qualified for their roles.
• Training Completion Rate: On-time completion of required QA and compliance training.

8. Documentation and Record Accuracy:

• Documentation Error Rate: Errors found in quality documentation or batch records.
• On-Time Document Review Rate: Timeliness of SOP and policy reviews and approvals.