QC Executive
Country:
Malaysia
Location:
Penang, MY
City:
Penang
Business Area:
Production
Employment type:
Full-time
Responsibilities:
- Lead & coordinate the QC inspectors to ensure all checking is performed to meet quality standard.
- Review all production records for accuracy and completeness before approving for final product releasing.
- Perform investigation of products defects with Production staff to eliminate the causes of quality issues and reduce the risk of failure.
- Analyse quality problems to identify root causes and implement corrective action.
- Reviewing quality records to ensure compliance and maintain files and documentation up to date.
- Ensure that all operations are performed with compliance to GMP, ISO 13485, FDA and other related standards.
- Establish training program for existing QC inspectors and new joined to ensure QC inspectors are properly trained.
- Established an effective and efficient visual inspection method to reduce human factors variation during inspection.
- Review and optimize QC inspection flow or plans.
- Provide support to new project development or material change projects.
Requirements:
- At least degree or above qualification with intermediate working experience under Quality or Manufacturing with a medical device company background.
- Able to work independently.
- Required language (written & spoken): English, Bahasa Malaysia.
- Computer literate such as Microsoft Excel, Microsoft Word & PowerPoint.
- Knowledge of ISO 13485, ISO 9001, FDA 21 CFR Part 820 are added advantage.