东莞招聘

(美国医疗设备行业巨头，新建亚太区研发中心，薪资优厚，有海外培训机会)
Job title: Quality Engineering Manager
Reports to： China VP R&D
Location: Shanghai

SUMMARY :

The QE Manager is responsible for the pertinent Quality & Regulatory Affairs deliverables outlined in the EM PDP RACI document, through the effective staffing, development, and deployment of Quality Engineering & Regulatory Affairs resources.

The quality engineering function is tasked with the following capabilities:

- Design for Six Sigma, reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a project team environment.

- Assure compliance to relevant procedures and industry standards.

- Evaluate component and sub-assembly suppliers to ensure device quality and conformance to standards and regulations.

- Ensures that components and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed, and validated.

- Perform or Review failure analysis to prevent or correct component and product failures as well as other risk management activities (e.g. FMEA's, QFD).

- Manage QA extended teams to assure adequate support for all projects. Manage and provide leadership to Senior Quality Engineers, Quality Engineers, Associate Quality Engineers and other personnel as necessary.

- Reviews and updates the Quality Engineering procedures to ensure compliance to current standards in the industry.

- Continuous improvement of their staff and procedures is expected to deliver high quality, profitable products with world-class TTM timelines.

PRINCIPAL DUTIES AND RESPONSIBILITIES:
· Member of EM PDT, reviewing projects with other cross-functional members to determine if projects should proceed, be terminated, or re-directed

· Ensure the effective recruitment of functional staff, work with Regulatory Affairs Director & VP China R&D to ensure effective sourcing of functional staff (both internal and external), and to ensure proper resourcing for the PDP pipeline

· Ensure the functional expertise of their group's members are competent, through training, development, and feedback

· Ensure their members have the equipment and procedures necessary to ensure consistent and effective execution of their RACI deliverables

· Collaborate with other cross-functional leaders of the EM PD organization to ensure projects move effectively and efficiently through the PDP

· Take active steps to collaborate with other cross-functional leaders to continually improve the PDP to improve TTM and ensure successful projects

· The specific capabilities of the leader & their staff are as follows:


1. Contributes as a member of product development teams representing the QA function throughout the Product Development Process.

2. Develops/ Reviews:

§ FMEA's (Application, Design and Process).

§ Process Flow analysis.

§ Cause and Effects Matrix

§ Process Control Plans.

§ Designed Experiments

§ Measurement Systems Analysis.

§ Process Capability Analysis.

§ Quality inspection procedures, including sampling plans, for production-level components and finished devices.

3. Performs/ Reviews:

§ Product reliability testing to facilitate continuous improvement.

§ Evaluation and documentation of Risk Assessments (ISO 14971).

§ First Article qualifications of components and subassemblies.

4. Contributes to the successful completion of Process Validation initiatives:

§ Write Validation Master Plans, and facilitate the qualification activities required to meet validation requirements.

§ Participate in the preparation of IQ, CQ, OQ, and PQ protocols, and write summary reports.

§ Perform statistical analysis of process data; interpret, compile and organize results.

5. Manages Sr. Quality Engineers, Quality Engineers and Associate Quality Engineers and other members of Quality assurance team as required.

6. Monitors supplier performance, and initiates corrective actions, as required.

7. Investigates suspected nonconforming materials and manages Material Review Board activities.

8. Ensures that all tasks are conducted in accordance with Quality System procedures and identifies/implements best practices.

Job Qualification:

Education:

Requires a B.S. degree in Engineering or associated fields, or equivalent industry experience. Advanced degree in Engineering or associated field preferred.
Experience:
Minimum 10 years experience in design, manufacturing, or quality engineering position (medical device experience preferred). Three years of experience can be substituted for an Advanced degree in related discipline.

Skills/Qualifications:

- Managerial skills required for leading and mentoring a team of Quality Engineers.

- ASQ Certified Quality Engineering (CQE), Certified Quality Auditor (CQA)

- Six Sigma Green Belt or Black Belt certified.

- Good written and oral communication skills.

- Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulation, ISO 13485, and CMDR requirements.

- Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer/software packages related to design, development, and manufacturing.

- Fluent in English & Mandarin

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