Senior Quality Engineer

Department: Quality

Reports To: Manager Quality

Job Summary:

The Quality Engineer is responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process. This role involves developing and implementing quality assurance strategies, overseeing production processes, managing product quality, and ensuring adherence to industry standards and regulations. This will include support for new product transfers.

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.

Work Environment:

Controlled Environment (Class 10K/100K cleanroom) and office area.