上海招聘

Job Description


POSITION TITLE:Quality Engineer
DEPARTMENT:RA/QA
BUSINESS UNIT:China R&D Center
REPORTS TO:Senior Quality Manager









SUMMARY OF POSITION:

Performs Quality Engineering functions in support of projects associated to product development / change including: risk management, CTQ, quality plan, sterilization validation etc. Act as a key team member to involve in other design activities such as design input, FMEA, design verification (Design for Six Sigma), reliability engineering, component specification / approval etc in a project team environment. Ensure that components and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed, and validated. Evaluate component and sub-assembly subcontractors to ensure device quality and conformance to standards and regulations. Manage QE extended teams to assure adequate support for all projects.


ESSENTIAL FUNCTIONS:

1. Contributes as a core team member of product development teams representing the QE function throughout the Product Development Process.
2. Develops:
§ Risk Management Plan/Reports, Risk Analysis
§ CTQs
§ Quality Plan
§ Control Plans.
§ Measurement Systems Analysis.
§ Quality inspection procedures, including sampling plans, for production-level components and finished devices
§ Sterilization Validation
§ Traceability Matrix.

3. Contributes to the successful completion of Process Validation initiatives:
§ Support for validation master plans, and develop quality requirements to meet validation requirements.
§ Participate in the preparation of IQ, OQ, and PQ protocols, and support to write summary reports.
§ Perform statistical analysis of process data; interpret, compile and organize results and reports.
4. Attend supplier qualification and PPAP
5. Investigates suspected nonconforming materials and manages Material Review Board activities.
6. Ensures that all tasks are conducted in accordance with Quality System procedures.
7. Collect, analyze and interpret statistical data.
8. Performs analyses and provide reports to management as required
9. Involve in QMS improvement and internal audit.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

1. Attend meetings as required, such as FMEA’s and Project Team meetings.
2. Assist with cross-functional team members in quality disciplines.
3. Travel to associated Covidien Manufacturing facilities and Suppliers in support of projects.
4. Assist manufacturing facilities in developing inspection methods.
5. Perform Gage R&R and correlation studies.
6. Work with manufacturing facilities on design transfer works.
7. Compile and issue monthly reports to management.
8. Develop appropriate job training assignments for associate QE function.
9. Other duties as assigned with or without accommodation


MINIMUM REQUIREMENTS:

Education required/ preferred: B.S. degree in Engineering or Electronic or Mechanical Science.
Experience:Minimum three (3) years experience in design, manufacturing, quality assurance or quality engineering position (medical device experience preferred). Experience with analytical tools and methods, including statistics (Minitab preferred), QFD and the use of computer software packages related to design, development, and manufacturing. Statistical Quality Control/Statistical Process Control. Design Of Experiments, Failure Mode and Effects Analysis. Experience in a regulated environment (FDA ISO, etc.).

Preferred Skills/Qualifications:
ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA). Good communication skills, both written and oral, and must be computer literate. Blueprint and specification reading. Experience with analytical tools and methods, including statistics (Minitab preferred), QFD, and the use of computer software packages related to design, development, and manufacturing. Geometric Dimension and Tolerance activities. Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485 and 14971 requirements. CE and QSR knowledge is preferred.


ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Reports to: Quality Manager

Job requires interaction with project team members as well as members of the QE extended team. Tracking timelines and facilitating the required Quality Engineering tools. Assure proper and consistent implementation of the quality engineering tools. Assure the project deliveries meet QMS requirement.

WORKING CONDITIONS:

Based in an office environment, but requires frequent presence in manufacturing, laboratory, customer and supplier facilities. Require some in vivo laboratory and surgical method observations.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

About Medtronic

Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.