Product Quality Assurance Specialist

3 days ago


Singapore COOK SOUTH EAST ASIA PTE LTD Full time
Job Description:

The Product Quality Assurance Specialist plays a pivotal role in ensuring the highest standards of quality for our products. Reporting to the QA Team Lead, you will be responsible for implementing and maintaining an effective Quality Control program across all aspects of the QMS of Singapore Distribution Centre (SADC) and Singapore Domestic Site (SDS).

Your key responsibilities include:

* Conducting Goods Inspection at various stages, such as receiving, stock check, returns, and reworks, to guarantee products meet quality requirements.
* Updating quality status in the system after inspection, if necessary.
* Performing inspection of Packaging Materials and Raw Materials (IFU / Booklets / Labels), engaging with suppliers, and handling Stop-Ships and responses to manufacturers.

You will also contribute to CAPA investigations, rework inspections, product recalls, and internal audits. Additionally, you will maintain quality records and documents, prepare QC reports, and train staff in QMS procedures. A strong understanding of ISO 13485 and GDPMDS standards is essential.

Requirements:
At least a Diploma/Degree in QA or a business-related discipline. Relevant experience in Medical Device quality assurance is advantageous. Knowledge of inspection equipment, measurement systems, and excellent communication skills are required. Document management and computer skills, including Microsoft Office, are also essential.

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