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At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.
In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.
We are in this for life.
We are changing the trajectory of human health, YOU CAN TOO.
We are searching for the best talent for STAFF QUALITY ENGINEER (TEMPORARY 24 MONTHS) to be in Cd. Juarez, Chihuahua, Mx. Salvarcar Plant.
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.
You will be responsible for:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- 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. Aids and executes investigation for non-conformities, audit observations, CAPAs and others.
- 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 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