Experience/ Knowledge/ Technical Skills Required:
- Diploma or Equivalent degree in any field with 2+ Years of experience and Preferably worked in the medical device manufacturing industry.
- Having prior experience with various measuring instruments.
- Must be good at MS Office – Excel and PowerPoint.
- Good communication skills – Written and verbal.
- Understanding of ISO 13485 requirements.
- Understanding the drawings and ensuring the list of measuring equipment are adequate.
- Propose new equipment if necessary upon discussing with the Manager -QA/RA.
- Maintaining the calibration log, coordinating with external labs for calibration, and ensuring that the equipment is calibrated on time (Both inhouse and external).
- Handling incoming, In process and Final inspection of the products.
- Responsible for affixing labels to inspected products before they are released to production.
- Identify Product Defects, Record and Report Issues.
- Handling supplier complaints.
- Support Process Improvements.
- Responsible for ensuring the quality of reworked products.
- Responsible for the Quarantine room.
- Initiating CAPAs for the process defects
- Support production with the preparation of product specifications and a history record (Batch manufacturing record).
- Ensure critical to quality and critical to safety dimensions are met according to drawings..