Job Description
Main Responsibilities
- Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team.
- Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement.
- Complete the evaluation and detailed investigation on the observed nonconformities during manufacturing process.
- Present accumulated quality data to customers and management.
- Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues.
- Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines.
- Support external quality inspections and execute internal and supplier audits.
- Complete assigned tasks on time with minimal supervision (self-motivated).
Requirements
- BS degree above or equivalent technical work experience.
- Clear / logical thinking with strong organization and communication skills
- Proficient problem solving skills.
- Working knowledge of Microsoft Office.
- Experience in the medical device industry is preferred.
- Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
- CQT (certified quality technician), CQE (certified quality engineer) is a plus.
- Six sigma green belt or black belt is a plus.
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