MANAGER/ASSISTANT MANAGER - QUALITY ASSURANCE, PSI

Job Description

OVERVIEW

• The incumbent is responsible to assist QA Manager to ensure the compliance with national and international standards such as ASTM, EN, JIS, ISO, NFPA and etc. Responsible for implementing policies, standards, and procedures for PSI.
  
  

DUTIES AND RESPONSIBILITIES

Business/ Operations

• Monitoring and controlling resources and overseeing the spending of money within budget
• Communicating technical information (oral and written)
• Implementing policies, standards, and procedures for PSI
• Managing quality testing, release control and documentation
• Conducting tests and inspections of products, or processes to evaluate quality or performance
• Investigating quality issues, and developing resolutions
• Addressing CAPA deficiencies focusing on effective corrective action and sustainable preventive action
• Developing training materials and providing training
• Managing customer's expectations and handling objections
• Assist QA Manager in monitoring, auditing, and updating of the existing Quality Assurance system.
• Assist QA Manager to ensure the compliance with national and international standards such as ASTM, EN, JIS, ISO, NFPA and etc.
• In the absence of QA Manager, to be responsible for the release of shipment once it meets the company set criteria and to the customer's requirements.
• Assist QA Manager in conducting supplier audit and handling any correspondence with customer and/or suppliers
• Assist QA Manager in handling customer complaints and to prepare for external quality audits.
• Plant & schedule work for reshipment to ensure proper distribution of assignments and adequate manpower.
• Supervising reshipments staff in carrying out tests and inspections with the assistance of Executives.
• Plant & conduct meetings with subordinates to ensure compliance with established practices, and to keep employees abreast of current changes and standards.
• Collating and analyzing performance data against defined parameters.
• Analyse reports to determine areas of improvement and determine appropriate plan of action.
• To assist QA Manager to review the SOP/WI in regard to Safety and Health issue.
• Any other task assigned by the superior.
  
  

People/ Stakeholder Management

• Leading a team of engineers, and executives preferably for a medium to large-scale manufacturing organization
• Navigating multiple stakeholders within the organization to achieve results
• Building cooperative working relationships within the organization
• Building enduring relationships with key customers
• Managing staff's performance and development.
• Ensure executives and reshipment staffs are adequately trained to perform their role and foster safety awareness.
• Identify relevant training needs, conduct training, and evaluate the effectiveness of the training.
  
  

REQUIREMENTS

Education:

• Minimum Bachelor’s Degree in Science or equivalent.
  
  

Work Experience:

• Minimum 6 years of working experience in manufacturing field.
  
  

Technical and Professional Knowledge:

• Good Manufacturing Practices (GMP).
• FDA QSR requirements as per 21 CFR 820.
• ISO Standards and requirements particularly ISO 13485 and ISO 9001.
• Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA) and problem- solving techniques.
  
  

Certification / License Requirement:

• N/A