Quality Control Engineer for Project

Peters Surgical International Co., Ltd. (Lat Krabang)

Lat Krabang

Bangkok, Thailand

Peters Surgical is a French company that designs, manufactures and distributes quality medical devices dedicated to surgical practice. Our know-how is particularly recognized for our Sutures, Manual Titanium Clips and Surgical Glue ranges.

About this position

The Quality Control Engineer for Project is responsible for managing the validation of test methods and equipment in QC and laboratory settings, ensuring compliance with established standards and protocols.

Responsibilities

Test method and equipment validation management
• Validation of test methods for QC and laboratory testing, such as physical and functional tests, by coordination with QC and laboratory teams.
• Validation of measuring and testing equipment or machines for QC and laboratory testing such as tensile testing machine, needle performance testing machines, incubator, oven and etc.
• Manage test method transfer from R&D and France team to QC and laboratory in Thailand.
• Issue protocol and report for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of test method validation and equipment validation/ qualification.
• Manage the validation of the test method and equipment timeline to comply with the Validation Master Plan.
• Manage new testing equipment qualification activity for new projects.
• Execute the implementation of new QC/LAB test method and equipment.
• Coordinate with QC/LAB/Production and Validation teams to execute output from the project for test method and equipment validation.

Requirements

Qualification:
• Education: Bachelor degree in Science or Engineering.
• Working experience: Minimum 3 years in QC/QA or validation function.
• Specific skill/knowledge: Able to use computer (excel, word, power point), have good knowledge of ISO 13485, ISO17025 (plus skill)
• General knowledge: Good command in English.