苏州招聘

SCOPE OF THE ROLE AND BASIC PURPOSE/职位与基本目的的范围

1. Responsible for creating and maintaining quality documentation for equipment, processes and products to assure the expected quality in accordance with all applicable requirements.
2. Determining handling of non-conformance during process control and preparation of corrective/preventive action plan.
3. Review in-process inspection/final inspection data, perform the trends analysis, and provide the suggestion for continuous improvement on process control.
4. Qualify inspectors to perform inspection and other activities related to manufacturing process.
5. Responsible for G R&R protocol/execution/report for in-process inspection.

ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标

1. Perform the principal duties of the Quality Engineer position
• Responsible for management of in-process inspection
• Discuss with Manufacturing Engineer and determine handling of non-conformance during manufacturing. If required, participate in the preparation of rework process
• Responsible for preparation of corrective and preventive actions with manufacturing together
• Responsible for preparation and maintenance of specification/requirements and inspection methods for in-process inspection and final inspection
2. Responsible for quality trends analysis for in-process/final inspection (Scrap, rework), provide the suggestion for continuous improvement on process control
3. Responsible for G R&R protocol/execution/report for in-process inspection
4. In accordance with DePuy Worldwide Quality strategy, participate to the development of the quality system and its day-to-day implementation:
• Participate in training or workshop employees and deploy on site the Quality philosophy based on FDA QSRs, ISO 9000/13485 and SFDA requirements.
• Ensures compliance to all GMPs and MDD requirements.
• Conduct internal and supplier quality audits at a Lead Auditor level as required.
5. Perform all job duties in full accordance with:
• The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information.
• All J&J policies and local regulations.
• The policies of the Health Care and Environmental programs.
• The code of conduct policies.
6. Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…).

Required Competencies and Skills/所需的能力与技能