南京招聘

DUTIES AND RESPONSIBILITIES:
1. Support Supplier Selection process by evaluating potential suppliers compliance with ISO13485 Medical Quality Systems, Lot Traceability, CoC, Audits, etc.. Plans, conducts and follows up on supplier quality system audits. Recommends changes in procedures, processes, design and/or equipment where necessary. Conduct Medical Supplier Audits for Cable, Connectors, and Unique Materials.

2. Establish and own Relationships with Quality Management at "Unique & Critical Suppliers"Establish Supplier Expectations concerning Quality Requirements. Monitor, Mentor and Improve Supplier Quality. Ensure that Supplier knows and understands that they can't change materials, manufacturing process or site without prior approval. Ensure Suppliers understand ISO13485 requirements and comply. Lot traceability enforcement.

3. Obtain all potential new supplier information as required (e.g. Supplier Audits, Quality Agreements, etc.). Also responsible to obtain all required supplier documents (e.g. ISO Certificate, BOS data, Supplier COC.

4. Responsible to managing all aspects of a "Quality portion of Supplier Scorecard"Collect input quality on the supplier's quality, ppm, dppm, cpk, rma's, capa's, and any relevant quality performance metrics to complete the Supplier Performance Evaluation scorecard.

5. Meet periodically with key suppliers to communicate the suppliers' performance and to assure the Medical Business Unit requirements are understood and/or corrective plans are in place.

6. Manage Supplier non-conformances.

7. Support the Medical Business Unit in the evaluation, selection, validation and qualification of new suppliers for commodities (wire, plating, tooling, packaging, etc. and services) as required.

8. Maintain effective and timely verbal and written communications.

9. Understand, support and contribute to current Total Quality Management (TQM), Six Sigma, International Standards Organization (ISO) and Environmental, Global Harmonization Task Force (GHTF), and/or Health and Safety (EH&S) Management Systems by following stated policies and procedures.

10. Serve and support Global Sourcing of Medical Business as deemed appropriate from time to time.


Requirments
1. Bachelor's degree in Engineering.
2. 3+ years in a Supplier Quality Engineering role. Experience in ISO quality systems.
3. Very Good verbal & written ENGLISH skills to clearly and concisely communicate globally.
4. Very Good interpersonal skills to work effectively with others.
5. Ability to read Quality System Documents, blueprints and BOM's.
6. Capable of making Quality recommendations and proposals.
7. Strong Understanding of Quality Systems Management.
8. Knowledge of Medical Quality requirements, including ISO 13485, FDA, IEC, ANSI/AAMI, UL, CE.

团队介绍