- Ensuring the Quality Management System (QMS) is always up to date according to the standards used as guidelines and monitoring the implementation of QMS is running well
- Design, implement, and maintain a Quality Management System (QMS) in accordance with ISO 13485 and CPAKB standards.
- Responsible for Internal and handle External Audit
- Manage all quality related documentation (procedures, work instructions, etc.) to ensure accuracy and compliance.
- Conduct internal training on quality procedures and policies.
- Make data analysis
- Monitor and evaluate trending product checking results related to Quality
Qualifications:
- Education, Bachelor's Degree in Bachelor's degree in Engineering or related field
- Minimum 2-3 years experience as a quality specialist, preferably in a manufacturing company
- Understanding the ISO 13485 and CPAKB standard is a must
- Having ISO 13485 Internal Auditor and Lead Auditor certification is a plus
- Good English language skills both verbal and writing
- Well organized and understand the importance of good document practices
- Understand and capable to working using Ms.Office
- Good analytical thinking
- Good communication skills and fast learning persons
- Located in Kopo Katapang (Kabupaten Bandung)