- Perform raw material testing (latex/nitrile, chemicals).
- Inspect incoming materials and packaging components.
- Carry out final inspection before product release.
- Ensure proper sampling plans (AQL standards) are followed.
- Maintain test records and ensure traceability.
- Conduct in-process and finished product testing, including:
- Tensile strength, Elongation, Thickness, Dimensions, Water leak test (pinholes), Powder/Residue analysis
- Maintain calibration and validation of testing equipment.
- Ensure compliance with relevant standards (ASTM, EN, ISO for gloves).
- Conduct line inspections and sampling checks.
- Ensure operators follow SOPs and quality standards.
C. Skills & Competencies
- Robust knowledge of:
- ISO 13485 / GMP
- Medical device regulations
- Documentation and reporting skills
- Good communication and teamwork abilities