Staff Quality Engineer

Staff Quality Engineer
Empresa:

Johnson & Johnson Family Of Companies


Staff Quality Engineer

Detalles de la oferta

Ciudad Juárez, Chih.“Johnson & Johnson companies are equal opportunity employers”The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.Biosense Webster, Inc. is recognized worldwide as a leader in the science behind the diagnosis and treatment of cardiac arrhythmias. We help patients around the world regain their health, their energy and their lives. Guided by the needs of electrophysiologists and cardiologists, Biosense Webster, Inc. has pioneered innovative technological advancements for more than 30 years. Join us as we continue to look for new and better ways to help physicians heal more hearts. Because that is what we do - we put lives back in rhythm.Searching the best talent for: STAFF QUALITY ENGINEERJOB SUMMARYThe 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 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 & RESPONSIBILITIESUnder 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 applicable.? Responsible and owner of the identification of material, material segregation, classification of the type of defects, including the successful application of these techniques in the day-to-day in manufacturing.? Analyzes/revises the effectiveness of the preventive and corrective actions.? Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.? Provides support for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level.Product Grading / Process? Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation.? Maintains and periodically checks the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer.? Develops, maintains and checks that the measuring methods are appropriate for the manufacturing process.? Provides support in the revision and maintenance of PFMEAs, Quality control plans, process instructions, and additional manufacturing documents.? Develops, interprets and properly implements process monitoring and control methods consistent with the risk level of the process/product.? Evaluates and interprets the causes of common vs special variation in the manufacturing process and determines the adequacy of the limits of the current processes.? Evaluates the need of risk mitigation techniques due to the product classification, potential types of defects, defect frequency, severity, patient risk, process capacity, process controls, etc. Determines the effectiveness of these techniques in the improvements previously implemented.? Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and documentation of the risk assessment such as FMEA of the process due to the changes in the product/process.Strategy? Collaborates with the quality leaders to identify the required quality engineering skills and competences that allow the execution of the strategic vision.People? Provides supervision, mentoring, coaching, performance revision, development plans and planning of the succession for others (when applies).? 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 Environmentalpractices 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 neededQualificationsQUALIFICATIONS:? As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable science. ? 6 to 8 years of work experience, or demonstrated performance.REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:? Use of computer packages. ? Ability to communicate in English, orally and written. ? Knowledge of product / process Risk Management (FDA and ISO regulations), preferably. ? Advanced technical training and experience in the use of Statistics and Lean methodologies and Six Sigma,including Measuring System Analysis, SPC, DOEs, reliability, etc. ? Strong knowledge of statistical software packages, preferably, with the capacity of pre-visualizing, create graphs and analyze data and be capable of presenting data that facilitates the taking of decisions. ? Ability to perform an “active involvement” in the solution of problems and resolution of problems, preferably. ? Capacity to solve problems and provide good judgment, highly desirable. ? Demonstrated management abilities of projects and leadership projects, preferably. ? Certifications such as CQA and CQE (preferably), CBA and Green Belt are a plus.ADDITIONAL POSITION REQUIREMENTS? Requires to work in a Controlled Manufacturing environment. ? This position requires desk work.RESPONSIBILITY FOR OTHERS (If applicable)? This position reports to Quality Operations Manager. ? Supervises and administers the group of auditors for the function of Quality Assurance and/or Quality Technicians, in addition works as a team with other functions to establish the priorities of the business and resources allocation.PHYSICAL WORKING CONDITIONS / REQUIREMENTS? This position will be performed in a clean room production controlled environment and office areas. ? Must be capable of standing for moderate periods of time and sit on a desk in front of a computer. ? Regular use of clean room tools, as well as office tools, necessary to perform the duties and responsibilities of this position.LOCATION & TRAVEL REQUIREMENTS? Location: Juarez, Mexico. ? Travel: This position may be required to travel up to 30% of the time."In Johnson & Johnson we recognize that differences in age, race, gender, nationality, sexual orientation, physical ability, thinking style and background bring richness to our work environments. Such differences help us connect better with the health needs of people in communities around the world.We believe that attracting, developing and retaining a base of employees that reflects the diversity of our customers is critical to our success. We also believe success hinges on relationships with diverse professional and patient organizations, civic groups and suppliers.Primar...

Requisitos

Auxiliar de logistica/sup. almacen/azcapotzalco - urgente/prestaciones superiores

Importante empresa a nivel internacional de sector logístico solicita con urgencia: DOCUMENTADOR, AUXILIAR DE TRÁFICO Ó AUXILIAR DE LOGÍSTICA REQUISITOS...


Desde Servi Temporal S.A. De C.V. - Ciudad de México (Distrito Federal)

Publicado hace un mes

Empleo de supervisor de ism

- -Cumplimiento del Sistema Internacional de Gestión de la Seguridad (ISM) -Elaborar y verificar procedimientos -Elaborar y verificar formatos -Auditar...


Tabasco

Publicado hace un mes

Empleo de supervisor seguridad e higiene

- Empresa agrcícola en el Valle de San Quintin BC, Ingeniería Industrial, Ambiental Químico TSU en Seguridad Industrial, Realizar planes y programas de...


Baja California

Publicado hace un mes

Empleo de supervisor seguridad e higiene

- OBJETIVO.- Salvaguardar la vida y preservar la salud y la integridad física de los trabajadores por medio de normas encaminadas a proporcionarles las...


Guanajuato

Publicado hace un mes