Associate QMS Engineer (9-month contract)

Mô tả Công việc

Responsibilities: This position is responsible for executing the established Quality Management System (QMS) elements within the company to ensure compliance with applicable requirements.

ESSENTIAL DUTIES

• Maintaining and supporting for document control, change control processes in compliance with ISO 13485 standard

• Updating Bill of Materials (BOM) in SAP for material specifications in Vietnam.

• Ensuring batch records align with manufacturing procedures and specifications to meet quality and regulatory requirements.

• Obtaining approval for Certificates of Compliance and releasing batches.

• Responsible for the proper storage management of quality records such as Device History Record, Validation Record…

• Administering Learning Management System (LMS), including managing training items, training assignments, training roles, and reporting

• Supporting training programs including but not limited to on boarding training, on the job training, QMS training…

• Fulfilling other duties as assigned by the supervisor

Yêu Cầu Công Việc

MINIMUM QUALIFICATION REQUIREMENTS 

Education 

• At least colleage’s degree or equivalent of education. 

Experience 

• Minimum working experience (year): not required 

• Preferred for education/training/experience of GMP, GLP, ISO 13485, validation, safety, pharmaceutical requirements and manufacturing control. 

Skills 

• Fimiliar with Microsoft office: excel, word. 

• Independent and team working  

• Communication skills. 

• Fair in English (verbal and written). 

-Or- 

An equivalent competency level acquired through a variation of these qualifications may be considered.