SENIOR QUALITY ENGINEER (DOS POSICIONES) (1 DE 2)

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.
njmedicaldevices.
om/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.
iosensewebster.
om JOB SUMMARY Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO , CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.
Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product.
May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
Shares technical expertise with others and helps develop junior level engineers.
DUTIES & RESPONSIBILITIES Under general direction and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
Primary responsibilities include working in Quality Engineering and with other functional groups in support of new product/process development, quality operations or quality assurance.
Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.
Develop and establish effective quality control and support associated risk management plans.
Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.
Ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.
Provide all planning necessary to ensure effective product acceptance.
This includes, but isnot limited to, part qualifications, specification development, and sampling plans.
Support vendor audits as technical lead as needed and support Supplier Quality as Quality representative as appropriate.
Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
Assist in complaint analysis as appropriate.
Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
Consults with supervisor and provide guidance as needed concerning unusual problems and developments.
Responsible for one or more of the following as needed.
o Supervise and/or provide guidance to Inspectors and Technicians in Quality LCM, Quality Operation or Quality Assurance activities.
o In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized engineering project or a number of small projects with varying levels of complexity.
o As an individual researcher, carries out assignments requiring the development of new or improved techniques or procedures.
o Work is expected to result in the development of new or improved techniques or procedures.
o Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary, data are insufficient or confirmation by testing is advisable.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring 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.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed Qualifications EXPERIENCE AND EDUCATION Bachelor’s degree in a related field, along with a minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required.
Master’s degree is preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable Ability to develop and implement Quality standards.
Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.