Operations and QA Engineer

Summary

Develop and maintain ISO-certified quality systems, document SOPs, and drive process improvements to ensure operational efficiency and compliance.

1. ISO Certification & Quality Management System

Lead and coordinate the company's preparation for ISO certification.
Develop, implement and maintain the company's Quality Management System (QMS).
Establish the required quality policies, procedures, processes, forms and records.
Conduct a gap assessment against the relevant ISO standard and develop an implementation roadmap.
Coordinate internal audits and support external certification audits.
Identify non-conformities and coordinate corrective and preventive actions (CAPA).
Monitor the effectiveness of corrective actions and ensure timely closure.
Maintain proper control of QMS documentation and records.
Ensure that relevant employees understand and comply with the company's quality requirements.

2. SOP & Process Documentation

Map and document key business and operational processes.
Develop and maintain Standard Operating Procedures (SOPs), work instructions, process flows and checklists.
Establish appropriate document-control procedures, including version control, approval and revision history.
Work with department heads and staff to ensure that documented procedures accurately reflect actual operations.
Identify gaps, duplication, inefficiencies and risks within existing processes.
Regularly review and update SOPs to reflect changes in operations, systems and regulatory requirements.

3. Operations & Process Improvement

Monitor operational processes and identify opportunities for improvement.
Analyse process performance using appropriate data and KPIs.
Investigate operational and quality issues and perform root-cause analysis.
Recommend and implement corrective and preventive actions.
Support continuous improvement initiatives to improve quality, productivity, efficiency and cost effectiveness.
Develop process controls to minimise errors, defects and operational risks.

4. Quality Control & Assurance

Establish appropriate quality-control procedures and inspection criteria where applicable.
Monitor quality performance and identify recurring quality issues.
Investigate internal and customer quality complaints.
Conduct root-cause analysis using appropriate tools such as 5 Why, Fishbone, Pareto analysis and 8D.
Establish and monitor quality KPIs.
Work with relevant teams to ensure corrective actions are implemented effectively.

5. Supplier & Customer Quality

Support supplier evaluation and quality monitoring.
Work with suppliers to resolve quality and process issues.
Assist in supplier corrective actions and follow-up.
Support the investigation and resolution of customer complaints and quality issues.
Maintain appropriate records relating to supplier and customer quality matters.

6. Training & Compliance

Develop training materials relating to SOPs, quality procedures and process requirements.
Conduct or coordinate employee training when new procedures are introduced.
Ensure employees understand and follow approved processes.
Monitor compliance and identify areas requiring further training or corrective action.

7. Management Reporting

Prepare regular reports on quality and operational performance.
Track key quality and operational KPIs.
Report significant quality issues, risks, corrective actions and improvement initiatives to management.
Provide recommendations to management based on process and quality data.