INGENIERO DE CALIDAD I
Publication date:
20 September 2024Workload:
100%Contract type:
Permanent position- Place of work:Johnson
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 Associate Engineer 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 associate will use quality engineering tools and practices for the effective and efficient development of transfers and product / processes 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 riskmanagement to prevent unanticipated failure modes and to improve the quality of the processes. This person will provide support to the business processes.
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 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 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.
- Establishes and properly maintains the required documentation of quality assurance activities and/or quality systems.
- Performs periodical audits of the line to evaluate GMPs, production controls, lot segregation and process audit according to JJPS. Checks the audits results of the area ton ensure that the corrective and preventive actions are adequate.Product quality, Control and Disposition and Performance Standards
- Conducts or supports investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs) and customer complaints. Escalation of quality problems when applies.
- Supports the analysis of the products related to customer complaints, to determine failure modes.
- Responsible and owner of the identification of material, material segregation, classification of the types of defects, including the successful application of these techniques in the day-to-day in manufacturing.
- Analyzes / revises the effectiveness of preventive and corrective actions.Product Grading / Process
- Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.
- Maintains and periodically revises the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.
- Provides support in the revision and maintenance of PEMEAs,Quality control plans, process instructions and additional manufacturing documents.
- Develops, interprets and properly implements process monitoring and control methods consistent with the process/product risk level.
- Evaluates and interprets common variation causes vs special in the manufacturing process and determine the adequacy of the current process limits.
- Evaluates the needs of risk mitigation techniques given the classification of the product, potential types of defects, defect frequency, severity, risk to the patient, process capacity, process control, etc.
- Determines the effectiveness of these techniques in the previously implemented improvements.
- Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and risk analysis documentation such as FMEA of the process given the changes in the product/process.Strategic
- Collaborates with other quality leaders to identify the quality engineering abilities required and competences to allow the execution of the strategic vision.People
- Provides supervision, mentoring, coaching, performance revision, development plans and succession planning for others (when applies).o Responsible for communicating business related issues or opportunities to next management levelo For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicableo Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedureso Performs other duties assigned as needed.