QA Manager

• Understand the company vision, mission and strategies
• Act as Management Representative for all external audits. This includes:

- Report on the Quality System Effectiveness to Management

- Managing and maintaining the regulatory / QMS documentation

- Maintain effective final release assurance

- Lead and ensure effective customer complaints handling and resolution

- Lead and ensure the effectiveness of internal audits

- Ensure effective control of non-conforming product

- Maintain the in-coming quality assurance system

- Assist in the process for supplier / vendor evaluation and ensure procedures are in the QMS

- Calibration of all product testing and qualification equipment

- Drive timely and effective CAPA resolution

- Ensure quality system is in compliance with regulatory requirements

• Participate in local Standards Committees
• Provide the necessary support for the new product, process and software validation
• Be the liaison person among the marketing, technical support and manufacturing functions for product improvement and matching to the plant’s capability
• Participate in and support continuous improvement initiatives
• Work to standardize processes across factories
• Participate in inter-plant audits as requested
• Develop subordinates through training, delegation, coaching and other techniques to maintain organization effectiveness
• Meet corporate compliance and SHE requirements
• Support implementation efforts of Six Sigma and World-Class Manufacturing in the plants
• Manage laboratory section to ensure that all laboratory activities comply to relevant standard requirements
• Manage QC section to ensure that all incoming, in-process and outgoing quality comply to regulatory requirements
• Any other duties as assigned by their superior
• Be a steering committee member
• Key player for the total business
• General administration
• Take roles, responsibilities and authorities as described in all company’s SOP’s, WI’s and all formal documentation seriously

• Bachelor’s degree in Sciences, Chemistry or related field
• Familiar with Medical Devices Application, Rubber, Latex or related
• Minimum 5 years experiences in Quality Control and Quality Assurances at Management level preferably in factory environment
• Knowledge of ISO requirements
• Knowledge of company's products is an advantage (Rubber, Latex, Medical Devices)
• Good computer literacy
• Good command of English and good interpersonal skill