QA - Customer Quality Engineer

Job Overview

The responsible area includes complaint handling process with customers, root cause investigation for product quality complaint, regulatory concern in critical quality event, post-market data analysis, and quality system activities. This position works closely with internal and external stakeholders to identify/ drive improvement initiatives in whole product lifecycle and quality management system so to ensure continuous product safety and effectiveness on the market.

Main Responsibilities

• Serve as company liaison with foreign customers and deliver outstanding customer service to resolve product quality complaints
1. Analyze complaint failure modes according to complaint descriptions, evaluation on returned defect samples, manufacturing records, and design history records
Complete technical investigation and root cause analysis with cross functional team members
2. Assess risk of failure mode confirmed during complaint investigation
3. Issue corrective and preventive action (CAPA) and verify the effectiveness of CAPA
4. Compose and submit a detailed and high quality report for the root cause investigation
5. Ensure proper product disposition of deficient product after they were released
• Escalate quality issues which may represent serious adverse event and reportable incidents, or the ones may require advisory notices to QA Manager
• Ability to effectively communicate and interact with foreign customers, team members, and various technical disciplines covering end-to-end product lifecycle (e.g. mechanical design, injection molding, plastics, metal, assembly, functional testing)
• Periodically complaint data analysis to identify actionable insights and continuous improvement for product/ process, and present complaint statistics to customers and management.
• Establish and maintain complaint investigation method and provide training to customer’s complaint handling center when required.
• Participate internal audits, and when required in external audits (customer or third-party audit)
• Responsible to follow the principle of GMP to the best of their ability at all the times


Skills and Qualification

• Bachelor or above degree in science or engineering background (e.g. mechanical, industrial engineering, biomedical, chemical engineering, material/life science)
• Logical thinking and proficient problem-solving skills
• Fluent English in speaking and writing with strong organizational and communication skills
• Ability as a team player to frequently cooperate with cross-function team members in different ways (e.g. phone call/meeting/e-mail)
• Time management ability to complete assigned jobs in a good timely manner
• Good flexibility/anti-stress ability to deal with different/urgent issues
• Below knowledge and qualification would be a plus
1. Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), or ISO 13485
2. Engineering experience or comparable experience in the medical device industry (e.g. quality engineering, design engineering, field application engineer)
3. Certified quality technician (CQT) or quality engineer (CQE)
4. Six sigma green belt or black belt
• Seniority level will be determined based on applicant’s qualification
• For candidate without relevant experiences, SHL provides complete on-the-job training with mentorship
riences, SHL provides complete on-the-job training with mentorship