Staff Quality Engineer

hace 7 meses

Ciudad Juarez, México Johnson & Johnson A tiempo completo

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.
Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

We are searching for the best talent for **STAFF QUALITY ENGINEER **to be in **Ciudad Juarez **.

**JOB SUMMARY**
The Quality Engineer Staff plans or adapts the new methods or procedures to control or coordinate all the aspects of several project at the same time and in the solution of the related and technical projects.
The engineer Staff is an emergent authority in a specific technical field, exercising a considerable freedom in the determination of the technical objectives of the assignments. In general, it is expected that his/her work result in the development of new or improved methods to reduce risks, equipment, materials, processes, products and technical methods. The Engineer Staff acts as a mentor for lower hierarchy personnel and provides advice to upper management about technical matters.
The Quality Engineer Staff will use tools and quality engineering practices for the effective and efficient development of transfers and maintenance of products / processes in the whole life cycle of the product. The holder of the position will also use the quality engineering principles and investigation
skills for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level, including those related to Escalations. He/she will use the appropriate risk management to prevent the unforeseen failure modes and improve the capacity of the processes. This
person will provide support to the business process and supervisor or direct technicians.

**DUTIES & RESPONSIBILITIES**
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 PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs.
Performs benchmarking to develop more effective methods to improve quality.
Establishes the metrics that are the quality indicators.
Provides support to the development of quality engineering and the compliance of the quality with the adequate abilities for the introduction of new products, and the management of the life cycle of the product.
Revises and approves the engineering change orders. (ECOs).
Establishes the categories of the quality costs and bases of the quality cost.

Compliance / Regulatory
Revises / analyzes if the current products and processes (including actions or decisions performed) comply with the regulations, such as the QSRs, ISO 13485, etc, including providing support during internal and external audits.
Participates in preparation 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.
Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems.
Performs periodical audits in the line to evaluate GMPs, production controls, lot segregation and audits to the process according to JJPS. Revises the audit results of the area to ensure that the corrective and preventive actions are adequate.

Finances
Controls and maintains the central budget of the department/cost.

New Products / Process Introduction
Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies.

Product Quality, Control and Disposition and Performance Standards
Directs and attends to Revision meetings of NCs as member of the MRB.
Conducts or supports the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and Escalation of quality problems when appl

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