Senior QA Technician

Responsibilities and Authorities

Provide quality control support through timely inspection / verification of materials, processes and products.

Perform engineering evaluation per test protocol and compile inspection records to facilitate traceability for demonstration of product compliance as instructed by QA/ QC Engineer.

Compile inspection records, approved COC/ CofA to facilitate traceability for demonstration of product compliance as well as customer complaint data for analysis by QA/QE Engineer.

Retrieve manufacturing test/calibration data as requested by customer.

Ensure appropriateness and completion of DHR as follows:

Test Results are within specifications

COA / COC are prepared and signed

Good Documentation Practice

Perform product/ process acceptance activities based on approved and released specifications and documentation as define in respective process SOP.

Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA  21CFR Part 820, OHSAS 18001 and WHO Good Distribution Practices requirements.

Support plant-wide activities and special projects, as assigned.

Qualification

GCE O Level, SPM, NTC 3 in (Mechanical or Electronics or Science (Biology, Chemistry, Bio-engineering) or equivalent.

Experience in quality function dealing with medical devices/IVD devices/Pharmaceutical, examples: Quality Control and inspection Equipment Calibration/ Testing Validation, etc.