美敦力临港工厂（Manufacturing Engieer和QA， 以及Sterilization Engineer）

Main Purpose:

• Responsible for the support of Manufacturing Operations, maintaining or improving the specified operational standards.

• Qualifies/Validates product/process according to schedule and follow up production until pass off requirement met.

Key Accountabilities:

• To provide technical support to production personnel and manufacturing lines.

• To develop, update and revise manufacturing documentation following standards, Medtronic internal policies and regulations established by regulatory agencies.

• To identify need, develop and provide adequate tooling and equipment to ease device manufacturability.

• Revises proposals for new product specifications or current specification modifications established by design documentation.

• To initiate, evaluate, approve and implement Engineering Change Order (ECR/ECO).

• To analyze and to determine conformance of materials and assemblies.

• To lead and / or to participate in development, training, qualification and validation activities for product or technology transfers.

• To train production personnel, and other engineers/technicians.

• Monitors and improves goals and metrics established for company and area of responsibility

• Ensures compliance with company policies, programs, procedures, regarding to government and regulatory agencies regulations (e.g. ISO, FDA, OSHA).  Ensure timely response to audit findings.

• Works with the Manufacturing and Supply Chain teams to apply principles, concepts and tools for capacity projects and Lean Sigma initiatives.

• Works and implements special projects as assigned by Direct Supervisor.

Attributes:

• Professional, cooperative, and customer service focused attitude

• Takes initiative to complete work tasks and works well in a team environment

• Leadership skills, team building and development

• Ability to initiate and lead process improvements

• Sensitivity to management’s needs and concerns

• Result and Quality Oriented

Experience and Knowledge:

• Minimum 3 years’ experience in Manufacturing Environment preferably in medical or electronic devices including supervisory experience.

• Experience in Lean Sigma Methodology and Continuous Improvements Programs.

• Good written reporting skills.

• Effective communication skills to deal with Team Members, Mfg. Supervisor and Q.A. Engineer to accomplish area goals and objectives.

• Fluent in both Mandarin and English language.

Qualifications:

• Degree in Engineering or related discipline / Diploma in Engineering or related discipline with relevant work experience.

 Acknowledgement by:

 __________________________________________________________________

Manager (Name/Signature)     Date

 __________________________________________________________________

Employee (Name/Signature)                               Date

Main Purpose:

• Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements. Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products. Participate on internal, inter-facility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, NMPA , FDA and ISO requirements.

Key Accountabilities:

• Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.

• Evaluate product/material discrepancies. (PRB/MRB) on time, and implement corrective actions accordant.

• Establish mechanism to evaluate, measure, monitor and/or quality in our products.

• Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers through evaluation/approval of Engineering change request/orders. Ensure update of manufacturing processes in order to reflect quality concepts and specification requirements.

• Support other Quality Engineer improvement and quality activities as needed.

• May provide guidance and assistance to less experienced engineer (eg. Quality Engineer I)

• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

• Ensure that processes comply, with a high confidence level, the tolerances stated on the product specification and drawings.

• Apply statistical tools in order to assure that processes comply with the specifications.

• Conduct failure investigations in order to initiate, stimulate, and assign corrective action.  Issue written reports and update, accordingly.

• Review and analyze quality trends with the manufacturing team. Analyze data based on trends, recommend actions for process, equipment and system improvement.

• Work on product transfers activities and actively participate in product qualifications and validations of equipment and processes.

• Perform risk assessment activities with reliability for product quality risks.

• Work on special projects assigned by Supervisor/Manager.

Attributes:

• Flexibility and adaptability

• Team Work

• Detail Oriented

• Patience and perseverance

• Accountable

• Aggressive practical personality capable of recognizing problems, causes, and providing solutions

• Effective oral and written communication skills  

• Effective interpersonal skills

Experience and Knowledge:

• Minimum 2 years of relevant experience preferably in a quality assurance or test-related capacity related to manufacturing of small electro/mechanical devices,  

•  Understanding of Statistical Process Controls and use of Minitab software is preferred.

•  Experience with medical devices

•  Must be fluent in both Mandarin and English language

•  Familiar with NMPA (CFDA), 21 CFR 820 and ISO 13485 requirements

Qualifications:

• Requires Bachelor Degree with preference in  Engineering or Science  or advanced degree  

 Acknowledgement by:

 __________________________________________________________________

Manager (Name/Signature)     Date

 __________________________________________________________________

Employee (Name/Signature)                               Date