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職位概要(Job summary):
Quasar’s Manufacturing Engineering Team has the responsibility of working with cross-functional teams comprising of Quality, Production, Supply Chain and Program Departments to achieve organization’s goals. Manufacturing Engineers own the processes for one or more product lines and are responsible for implementing Continuous Improvement Projects (CIPs), working together with RFQ Engineer to provide accurate Technical Costing and building samples for new projects. Manufacturing Engineers works closely with Advanced Engineering Team and New Product Introduction (NPI) Team to execute a clean handover of projects from NPI to Mass Production.
工作職責(Responsibilities):
1.Health & Safety: Ensure that all Health, Safety and Environmental requirements are fulfilled for the manufacturing process.
2.Quality: Drive Engineering solutions to ensure Right First-Time principles, driving yield improvements, complaint reductions, supporting the CAPA process, and audit prep activities.
3.Continuous Improvement: Own the manufacturing process, work with key business stakeholders and operations teams to assess process capabilities, improve process efficiency, reduce cycle time.
4.Service: Drives a culture of Exceptional Customer Experience (ECE) for both the Internal and External customers, by ensuring that projects and commitments and continually being met or exceeded.
5.New opportunity sample build: Conduct the new opportunity sample build, by ensuring that product and commitments being met or showing manufacture capability to customer.
6.Responsible for managing the overall process performance through the appropriate use of Lean Manufacturing tools and techniques (TPM etc.).
7.Responsible for preparing validation protocol of OQ&PQ/PV for additional TJ/equipment, and process period to mass production.
8.Develop and manage SOPs/manufacturing standards/operations standard work as required in compliance with engineering change control process (ECO).
9.Investigating in state-of-the-art process technologies and evaluating potential competitive advantage and the cost-benefit of introduction.
10.Maintain high quality / compliance standards in line with Medical Devices manufacturing requirements.
11.Drive MP product to keep stably high manufacturing yield.
12.Manage a variable workload to meet operational requirements.
任職資格(Qualification):
Qualifications:
1.A bachelor degree or above, fresh graduate can be considered.
2.Good understanding in the use of lean and quality tools in a manufacturing environment.
3.Interpersonal, communication Problem solving, Analytical and lateral thinking skills.
4.Good quality mindset, and FDA, ISO 13485 and medical device knowledge would be advantage.
5.Fluent English skills (written and spoken) .