Essential Duties and Responsibilities:
1. Quality Assurance and Control:
- Develop, implement, and maintain quality assurance plans, procedures, and control measures.
- Monitor and analyse production processes to detect and resolve quality issues.
- Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standards.
- Support internal and external audits and regulatory inspections.
- Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive actions.
- Ensure the non-conformance or quality issue is resolved and complete in a timely manner.
- Participate in new product introductions to ensure quality is built into all products early in their life cycle
- Support validation processes including IQ, OQ, PQ, process validation and test method validation.
2. Process Improvement
- Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
- Lead and drive QA initiatives across the product areas
- Lead or participate in root cause analysis and corrective action planning.
- Support and drive cost improvement project
3. Customer Interaction:
- Address customer complaints and feedback related to product quality.
- Work closely with customers to understand their quality requirements and ensure that products meet their specifications.
- Communicated on any potential change request of the processes to customer.
- Provide technical support and quality-related information to customers.
4. Documentation and Reporting:
- Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
- Prepare and support monthly / annual quality reports to management and other stakeholders.
- Ensure proper documentation and traceability throughout the manufacturing process.
5. Training and Development:
- Train manufacturing staff on quality standards, procedures, and best practices.
- Promote a culture of quality and continuous improvement within the organization.
Education/Experience and Qualifications:
- Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing.
- Diploma holders in Engineering or science with more than 5 years experience in Quality are welcomed to apply
- Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.
- Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.
