Engineer II, Quality Engineering

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• 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.

• 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

• 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.

• 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.

• Training and Development:

-        Train manufacturing staff on quality standards, procedures, and best practices.

-        Promote a culture of quality and continuous improvement within the organization.

Authority:

• To approve process / product related forms, work instruction and procedures.

• To approve the risk assessment file.

• Authorize to sign on the Certificate of Analysis.

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 may be considered.

• Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standards.

• Good command of English language.

• Strong analytical and problem-solving skills, with the ability to troubleshoot complex issues.

• Able to effectively collaborate with cross-functional teams and present information clearly.