该职位来源于猎聘 Main responsibilities:
- Comply with company polices, including employee manual, and quality& Safety policy and procedures.
- Conduct the production process engineering development& implementation;
- organize the process validation and its maintenance, which applicable for defined key processes.
- Implement the applicable requirement of certification ISO13485 system and ISO 14001 system.
- Ensures continuous compliance of product quality, safety, delivery and efficiency, and drive their improvement by effective projects implementation.
- Organize investigation and analysis activities for process nonconformity and customer complaints, contribute the know-how and experience from involved processes to resolve the case effectively.
- Design the new product based on requirements of customer and final confirmation.
- Support to products registration and clinical trial project.
- Support to production engineering in SOP & PFMEA from product pilot run to mass production lots, according to corporate product/process specification., to achieve standardization of production processes in product quality.
- Responsible for product service manual management and product training.
- Leading projects of cost down, workflow improvement, production efficiency improvement, product quality improvements
- Comply with relevant product applicable standards/specification, to perform technical reviewing with the corporate and local supplier, get BU approval, with respect to corporate and local quality requirement.
- Conduct and complete new product/component design or engineering change, including design validation and verification and communication with corporate business unit.
- Other tasks assigned by the direct supervisor. Required Knowledge/Skills/Experience:
- Over 5 years' experience as production engineering in US/EU Company with GMP qualified is preferred.
- Shall hold college degree or above, major in science or engineering is preferred.
- Shall be fluent in oral and written English is necessary, good communications skills.
- Shall have the experience in design of experiment, knowing the solid works is preferred.
- Good analytical thinking, problem-solving and innovative skills
- Good mathematical and statistical ability
- Good communication skills for fully understanding customer requirements in quality, use and cost aspects. Personal qualities:
- Strong responsibility, good in self-management
- Good team player