職位描述：

職位概要(Job summary): 
Overall responsibility for the equipment (Machine, Jig and Tools) design, development, introduction, improvement and qualification for product manufacturing.

工作職責(Responsibilities): 
Lead equipment development projects
Equipment development project proposal
Equipment development concept verification
SOW & Risk analysis and mitigation
Equipment supplier evaluation
Equipment design & design review and verification
Equipment manufacture, delivery follow up
Equipment acceptance test, FAT/SAT
Equipment operation manual, specification, technical drawings
Equipment installation and debugging
Equipment operational tuning
Equipment improvement 
Equipment verification
Equipment operation and maintenance work instruction
Equipment validation - validation protocol, execution and report
Equipment training to equipment maintenance team and production team
Equipment change and upgrading
Deal with other assignments assigned by superior.

任職資格(Qualification) :
Bachelor Engineering degree or above, major in mechanical, automation or electronic 
8 years or above equipment design and development working experience
Good Communication skills and English level.

職位描述：

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 ***-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) :
1. A bachelor degree or above, at least 6 years relevant working experience.
2. Varied experience of launching new products into manufacture using a phase gated approach.
3. Good understanding in the use of lean and quality tools in a manufacturing environment.
4. Interpersonal, communication Problem solving, Analytical and lateral thinking skills.
5. Good quality mindset,  FDA, ISO 13485 and medical device knowledge would be advantage.
6. Fluent English skills (written and spoken).
7. Professional, organized, passionate and self- motivated.

職位描述：

職位概要(Job summary): 
The Regulatory Compliance Sr. Engineer is to monitor and ensure the compliance to external standards/requirements and Quasar Quality System Requirements in Quasar manufacturing site.
 工作職責(Responsibilities): 
1. Conduct routine monitoring, checking program to identify site compliance gaps and follow up gap remediation. 
2. Participate in Corporate Procedure Development & Maintenance. Join Corporate audit on other sites when required.
3. Provide Regulation Compliance supporting on critical business projects, when necessary, e.g., MAH
4. Facilitate critical external audits/inspection at site. e.g., FDA inspection, NMPA audits. 
5. Join cross sites QMS IT system coordination and maintenance.
6. Responsible for liaising with the company’s internal/external stakeholders to identify/understand the required Regulatory Compliance knowledge needed to provide the required expertise and advice.
7. Other tasks assigned by leader.

任職資格(Qualification) :
1. Bachelor or Master’s degree in science related field. 
2. Minimum of 5 years’ experiences on Medical Device or Pharmaceutical Industry Quality Regulatory Compliance related work. Knowledgeable on international standards or Health Authorities regulations requirement.
3. Good oral and written communication skills both in English and Chinese.
4. Good interpersonal and influential skills.
5. Ability to work under pressure in a dynamic environment.