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"“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 ENGINEER
SECTION 1: 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.
SECTION 2: 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 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).
o Responsible for communicating business related issues or opportunities to next management
level
o 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 applicable
o Responsible for ensuring personal and Company compliance with all Federal, State, local and
Company regulations, policies, and procedures
o Performs other duties assigned as needed
Calificaciones
SECTION 3: EXPERIENCE AND EDUCATION*
- As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable
science.
- 6 to 8 years of work experience, or demonstrated performance
AFFILIATIONS*
- 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 previsualizing,
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.
""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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status”
Ubicación principal
México-Chihuahua-Ciudad Juárez- Organización
Cordis de Mexico S.A. de C.V. (8286)
Área
Ingeniería
Requisition ID
2005846837W"
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