Quality Engineer

工作内容

Job Description :

1.Responsible to follow all applicable SOPs and WIs at all the times.

2.Responsible to follow the principle of GMP to the best of their ability at all times.

3. This job holder is capable of implementing job tasks below,

• Author procedures, work instructions or other documents.
• Review completeness of the Device History Records.
• Issue Corrective and Preventive Actions (CAPA), leads cross functional team to perform root cause analysis and identify corrective actions.
• Verify the effectiveness of corrective/preventive actions.
• Assist QA Manager by participating in Non-Conforming Product, complaint, CAPA investigation.
• Provide training to other function members in QA systems.
• Participate in internal audits, and when require external audits.
• Interfaces with other functions’ members, customers and/ or suppliers to resolve issues.
• Lead and draft Supplier Quality Agreement.
• Evaluate and audit supplier (routine and ad hoc).
• Review and approves supplier failure analysis relative to corrective action provided, and coordinate resolution of quality assurance related problems.
• Identify, investigate, analyze and correcte problems in quality, production and control at a supplier locations, and escalate to QA Manager if any major systemic/production failures observed.
• Drive supplier quality performance improvements.

4. Assign above job tasks by staffing qualification / personal ability / organization needs.

5. Carry out other duties as assigned.

Qualification :

• Compliant to ISO 13485 standard with Risk management approach
• Logic thinking and good communication skill with varying technical experts
• Great Root cause analysis skills
• Strong on Writing/Reading in English (TOEIC:700)