STAFF QUALITY ENGINEER

En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad.

La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y consumidores todos los días durante más de 130 años. Independientemente de su raza, creencia, orientación sexual, religión o cualquier otro rasgo, TÚ eres bienvenido en todos los puestos vacantes en la compañía de cuidado de la salud más grande del mundo.

Cuando te unes a Johnson & Johnson, tu movimiento podría significar nuestro próximo avance.

En Johnson & Johnson Medical Devices Companies, utilizamos nuestro alcance, escala y experiencia para reinventar la manera en que se brinda atención médica y ayudar a las personas a vivir más tiempo y de manera más saludable.

En un entorno sumamente cambiante, establecemos conexiones entre la ciencia y la tecnología para combinar nuestros propios conocimientos especializados en soluciones quirúrgicas, ortopédicas e intervencionistas a fin de diseñar y ofrecer productos y servicios centrados en el paciente.

Estamos en esto de por vida.

Estamos cambiando la trayectoria de la salud humana, TU TAMBIÉN PUEDES.

Por favor visita: https://www.jnjmedicaldevices.com/es-419 para más información.

Biosense Webster, Inc. es reconocido mundialmente como líder en la ciencia detrás del diagnóstico y tratamiento de las arritmias cardíacas. Guiado por las necesidades de electrofisiólogos y cardiólogos. Biosense Webster, ha sido pionero en avances tecnológicos innovadores durante más de 30 años. Algunos podrían llamar a esto toda una herencia, pero es sólo el comienzo. Para obtener más información, visite www.biosensewebster.com

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 I 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 I analysis of the effectiveness of POCA, 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.

• Provi des support to the devel opment of qual i ty engineering and the compl i ance of the qual i ty with the adequate abi l i ties for the i ntrodu cti on of new products, and the management of the l ife cycle of the product.
• Revises and approves the engineering change orders.(ECOs).
• Estab l ishes the categori es of the qual i ty costs and bases of the qual i ty cost.

Compliance I Regul atory

• Revises I analyzes i f the current products and processes(incl udi ng acti ons or deci si ons performed) compl y with the regul ati ons, such as the QSRs, I SO 13485, etc, i ncl udi ng provi di ng support during i nternal and external audi ts.
• Participates i n preparati on acti vi ti es for/or interactions wi th regul a tory agenci es( FDA, JJ RC, BSI, etc.).
• Responds to internal or external audi t observations rel ated to the functi on of qual i ty engi neeri ng.
• Properly establ i shes and mai ntai ns the requi red documentati on of qual ity assuran ce acti vi ti es and/or quality systems.
• Performs periodi cal audi ts i n the li ne to e val uate GMPs, producti on control s, l ot segregati on and audits to the process accordi ng 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 I Process I ntroducti on

• Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies.

Product Qual i ty, Control and Dispositi on and Performance Standards

• Directs and attends to Revision meetings of NCs as member of the MRB.
• Condu cts or supports the i nvesti gati ons, boundi ng, documenta tion, revi si on and approval of the non-conformities( NCs), preventive and corrective actions(CAPAs), customer complai nts and Escal a tion of qual ity probl ems when appl i cab l e.
• Responsi bl e and owner of the i denti ficati on of materi al, material segregati on, cl assificati on of the type of defects, i ncl udi ng the su ccessful appl i cati on of these techni ques i n the day-to-day i n manufacturing.
• Analyzes/revises the effectiveness of the preventi ve and corrective actions.
• Defines sampl ing pl ans and approves i nspecti on methods for eval uati on and acceptance of components and finished product.
• Provi des support for the resol uti on of compl ex probl ems( techni cally) associ ated to the manufacturing process at a l ocal or fran chise l evel.