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Quality Engineer

3 weeks ago

Singapore Revvity Full time

Customer Quality Management: Overseeing all aspects of customer quality, including
- Collaborating closely with the Complaint Handling Unit (CHU) team to address customer complaints promptly and effectively.
- Conducting product technical reviews and updating Post Market Surveillance Reports to ensure compliance with regulatory requirements and address any quality-related issues identified.
- Product and Process Quality Management: Responsible for ensuring manufacturing processes adhere to quality standards and specifications. This entails:

- Monitoring process performance and conducting audits to identify areas for improvement.
- Implementing enhancements to elevate product quality and consistency.
- Overseeing the release of finished goods to ensure compliance with quality standards.
- Managing qualification processes for tools, equipment, and software to guarantee they meet quality requirements.
- Quality Management System (QMS) : Supporting various aspects of the quality management system, including
- Internal Audit: Plan, conduct, and follow up on the internal audit closure
- External Audit: Support external audit activity
- Manage and coordinate the TUV regular site inspection.
- corrective and preventive actions (CAPA), change control, and risk management. This may involve developing and maintaining QMS procedures and ensuring compliance with relevant standards and regulations.
- Regulatory Compliance: Ensuring compliance with regulatory requirements and standards which shall include, but not limited to ISO9001, ISO13485, IVDR, and QSR820 as applicable to the product and manufacturing processes.
- Supplier Quality Management: Backup to support the Supplier Quality Engineer and collaborating with suppliers to ensure the quality of incoming materials and components.
- New Product Development: Manage quality deliverables in NPI projects, including the creation of control documentation, establishing process control, and training of quality inspectors, if any.
- Cross-functional Collaboration: Working closely with cross-functional teams, including engineering, manufacturing, procurement, and customer service, to address quality
- related issues, drive quality improvements, change control management, and support overall business objectives.