Document Control Change Analyst Quality

hace 3 semanas

Ciudad Juarez, México Claremont Consulting A tiempo completo

**Change Document Control Analyst 2**

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products, solutions and help people live longer, healthier lives. And you can be part of it too. Whith Ethicon

**JOB SUMMARY**

The Change Control Analyst will play an important role in executing the change control processes for changes to Device Master Records, Quality System Record data, QAD System, CPDM, ADAPTIV, and/or documents in the Product Lifecycle Management (PLM) system, providing internal customers with guidance in following change control procedures and ensuring changes conform to established standards.

**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 will be responsible for the following:

- Review document changes submitted for accuracy and consistency with other documents.
- Review changes and implementation plan based on the description/rationale and the sites/functions affected.
- Analyze Change Orders and submit for approval in a timely manner.
- Proofreads and edits documents for style, grammar, spelling, format and impact it may have on other documentation.
- Provide guidance to change originators, system users, and other internal customers in change control processes and system tools
- Assist in conducting internal audits of the change management process.
- Verify change implementation and approves closure of completed change orders.
- Collaborate with relevant personnel to ensure accuracy of any document revisions.
- Support process improvements and assist in implementation.
- Provide support during internal and external audits.
- Generate reports and metrics on the change process as needed.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned 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

**EXPERIENCE**

2-4 years of experience related to the position (Medical Company)

Bachelor degree or Actualy Estudent of Engenieer or related field to medical manufacturing
- Bilingual or Fluent in English
- Experience in Electronic change control processes and PLM systems (i.e. Windchill, ADAPTIV, etc.) in a regulated industry is highly desirable.
- GMP/ ISO knowledge preferred.
- Ability to organize, prioritize, and handle multiple projects simultaneously.
- This position travels infrequently.

Tipo de puesto: Tiempo completo

Salario: $22,780.00 - $24,000.00 al mes

Horario:

- Turno de 8 horas

Consideraciones ante el COVID-19:
Mascarilla, desinfección, medidas de Seguridad e Higiene de acuerdo a las regulaciones estatales y federales

Puede trasladarse/mudarse:

- 32599, Juárez, Chih.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)

Educación:

- Técnico superior terminado (Obligatorio)

Experiência:

- Document Control Change Anayst: 2 años (Obligatorio)

Idioma:

- Inglés Avanzado (Obligatorio)

Disponibilidad para viajar:

- 50 % (Deseable)

Lugar de trabajo: Una ubicación

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