Johnson & Johnson Careers
Customer Technical Service
Requisition ID: 1805658353W
Business Improvements 业务改进
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
支持工厂的内外部审核，遵守适用的法规和标准(例如QSRs, ISO, EN和MDD)要求。
- Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction 新产品/制程导入
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Supports new product introduction as part of design transfer.
Product Quality, Control & Disposition and Performance Standards产品质量控制处理和执行
- Supports activities related to the Material Review Board.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
Product/Process Validation 产品/过程确认
- Approve IQ, OQ, PQ, TMV or Software Validation.
Production/Process Controls including Control Plans产品/过程控制包括控制计划
- Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
- Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Develop, interpret and implement standard and non-standard sampling plans.
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
- A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally requires 2-4 years related experience.
- Experience working in both an FDA and European regulatory environment is preferred.
- This position will require relevant experience working in manufacturing/operations.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
Johnson & Johnson Medical Suzhou Ltd. (7054)
Customer Technical Service