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The Quality EngineerI plans, provides support to engineering projects or studies. Applies engineering principles and practices within the assigned areas. Can coordinate and direct personnel activities of technical support and is responsible for the technical development of the personnel assigned. The quality engineer I will use quality engineering tools and practices for the effective and efficient development of transfers and product/process maintenance in the complete life cycle of the product. The holder of this position will also use his/her abilities of investigation and problem resolution to improve and maintain the products/processes that are aligned with the quality and global business vision. He/she will use the appropriate risk management to prevent unanticipated failure modes and to improve the quality of the processes. This person will provide support to the business processes
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:Business Improvement-Revision / analysis of the effectiveness of problem resolution techniques such as (PCDA),Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.Compliance / Regulatory-Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc. including providing support duringscheduledinternal and external audits.Participates in quality readiness and in activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).Responds to internal or external audit observations related to the function of quality engineering.Establishes and properly maintains the required documentation of quality engineering activities and/or quality systems.
**Qualifications**:
.Bachelor's in engineering: Mechanical, Electrical, Industrial or applicable science.0 to 2 years of work experience or demonstrated performance.