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Associate Quality Engineer

Associate Quality Engineer
Empresa:

J&J Family Of Companies


Detalles de la oferta

"“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: ASSOCIATE QUALITY ENGINEER

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 risk management to prevent unanticipated failure modes and to improve the quality of the processes. This person will provide support to the business

processes.

If CSS Position: This position will have responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of multiple product platforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical
Aesthetics.

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).

- 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
Calificaciones

QUALIFICATIONS:

- Bachelor in Engineering: Mechanical, Electrical, Industrial or applicable science.

- 0 to 2 years of work experience, or demonstrated performance.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

- Statistics knowledge

- Use of computer packages.

- Ability to communicate in English, orally and in writing.
- Knowledge of engineering fundaments.
- Knowledge of the Product Risk Management / process (FDA and ISO regulations) is preferable.

- Ability to perform “active involvement” in the solution of problems and resolution problems, preferable. Capacity to solve problems by providing good judgment, highly desired.

- CQA certification (preferably.

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 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 does not travel frequently.
""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

2005843063W"
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Requisitos


Conocimientos:
Associate Quality Engineer
Empresa:

J&J Family Of Companies


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