Quality System Engineer
- Batu Kawan, Pulau Pinang
- Tetap
- Sepenuh masa
- Coordinate the return of product samples; perform visual inspection and preliminary investigations related to product issues; forward samples and preliminary investigation reports to responsible departments; review the responses; and notify the customer of the result.
- Partner with Field Service, Marketing, Manufacturing, Quality and Sales personnel to help resolve customer issues.
- Partner with manufacturing facilities to analyze failure, CAPA to respond to customer complaints (PIR).
- Actively provide individual contributions in problem solving efforts to improve quality.
- The incumbent may be asked to perform other function-related activities in addition to the above mentioned responsibilities as reasonably required by business needs.
- Comply with the ISO14001 Environmental Management System policy, SOP and requirements
- Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
- Perform other tasks as required.
- Demonstrated analytical skills
- Effective interpersonal skills
- Demonstrated written communication skills
- Strong verbal communication and listening skills
- Demonstrated problem-solving skills
- Assumes personal responsibility for actions
- Good Team Player
- Proficient in English written and verbal communication skills
- Knowledge of ISO in a regulated industry (Medical Devices, Aerospace, Automotive, etc.) preferred: ISO 13485 & 21 CFR 820, MDD & MDR regulations/guidelines - Preferred
- Class II or Class III medical devices requirements - Preferred