Qc & Logistics Specialist

Duties & Responsibilities:

• Responsible in quality control: responsible in maintaining and enhancing the internal processes in compliance to the local medical device regulations and the company’s regulations.
• Develop and maintain Quality Manual Documents and Standard Operating Procedures to meet the regulations.
• Assure all the quality assessments results required by national regulations and maintain properly.
• Keep up to date with documents’ revision.
• Manage Quality records to meet the regulatory requirements.
• Manage the local language labeling requirements.
• Coordinate customer feedback and maintain the records.
• Input customer feedback into SalesForce.com.
• Collect and aggregate return authorization materials.
• Manage daily operations at warehouse and work with 3PL to assure that corresponding procedures are implemented and maintained.
• Identify solutions to meet regulatory requirements from internal and external parties.
• Manage government owned organizations request and successfully respond and complete.
• Input daily transactions into ERP system.
• Maintain daily transactions into ERP to be accurately archived.
• Pack a shipment and arrange a courier service to ship out to HQ.
• Perform ad hoc requests or special projects as assigned.

Minimum Qualification:

• Bachelor of Science
• Understanding of KGMP, related Medical Device Acts, and etc.
• Hands on experience with Quality Documentation
• PC literate with MS Office Suite (Excel and Word)
• Good communication skills
• Must be able to regularly lift up to 15 Kg
• Must be able to work with minimum supervision

Preferred Qualification:

• Work experience as a Quality Officer and representative in Medical Device Industry

Education:

• University diploma is required
• Physical requirements / Work Environment

This position primarily works in an office. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. Must be able to regularly lift up to 35 pounds. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.