Work Flexibility: Onsite
KEY RESPONSIBILITIES / DUTIES:
Responsible for developing applying revising and maintaining quality standards/procedures to support manufacturing activities. Making sure the GMP and ISO13485 requirements are implemented correctly and followed strictly.
- Review NC report to check its compliance to procedure requirements and ensure proper NC/CAPA process is followed strictly
- Maintain NC/CAPA log system to ensure its accuracy
- Support CAPA Leader to manage CAPA metrics and prepare weekly/monthly report
- Support CAPA Leader to deliver the required NC/CAPA training and improve CAPA process
- DCC related work independently (maintain document master list record archiving distribution & retrieval)
- CM related work independently (ECR scan & registration Coordinate Basic Windchill training & testing)
- Other task assigned by supervisor
SUPERVISORY RESPONSIBILITIES:
REQUIRED SKILL SET
- Excellent logical thinking
- Effective interpersonal and trouble-shooting skills
- Good communication skills and training skills.
- Basic PC skills & good operation skills of Excel
- Quick learner
RELEVANT EXPERIENCE
- 1-3 years in Quality Assurance or related functional area preferred
- Experience in GMP or ISO quality systems
EDUCATION
- College / B.S. in engineering or engineering related discipline.
Travel Percentage: None
Required Experience:
Senior IC