Quality Assurance Engineer

Position Summary

The Quality Assurance Engineer is responsible for developing, implementing, and maintaining quality assurance and control systems to ensure that products meet or exceed customer and regulatory requirements. This role plays a critical part in supporting audits, driving process improvements, resolving product quality issues, and fostering a culture of continuous improvement within the organization.

Essential Duties and Responsibilities

Quality Assurance and Control:

• Develop, implement, and maintain quality assurance plans, procedures, and control measures.
• Monitor and analyze 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 non-conformance or quality issues are resolved and completed 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.

Process Improvement:

• Identify opportunities for process improvements to enhance product quality and manufacturing efficiency.
• Lead and drive QA initiatives across product areas.
• Lead or participate in root cause analysis and corrective action planning.
• Support and drive cost improvement projects.

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.
• Communicate any potential process change requests to customers.
• Provide technical support and quality-related information to customers.

Documentation and Reporting:

• Maintain comprehensive records of quality control activities, inspection results, and non-conformance reports.
• Prepare and support monthly and annual quality reports to management and other stakeholders.
• Ensure proper documentation and traceability throughout the manufacturing process.

Training and Development:

• Train manufacturing staff on quality standards, procedures, and best practices.
• Promote a culture of quality and continuous improvement within the organization.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum [X] years of experience in quality assurance, preferably in a regulated manufacturing environment.
• Strong knowledge of FDA, ISO 13485, and other relevant quality standards.
• Experience with validation processes (IQ, OQ, PQ), root cause analysis, and CAPA.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work collaboratively across departments and with external customers.
Proficient in quality management systems and relevant software tools

We will go through your application and update you if you are shortlisted.

However, rest assured that all applications will be updated to our talent bank for future opportunities

EA Personnel Name: Lian Cher Chieh
EA Personnel Reg. no.: R1217705
EA License no.: 25C2810EA