Environmental and Sterilization Quality Engineer

hace 5 días

Tijuana, México Carlisle Companies A tiempo completo

Minimum Requirements:

- Bachelor's degree on Microbiology, Biochemical Engineering, QFB, or similar
- Experience in medical manufacturing environment conditions and controls
- Knowledge Environmental/Sterilization process and applicable standards
- Knowledge of ISO 13485:2016, CFR 21, Cofepris, and other applicable standards
- Bilingual, English 80%
- Teamwork focus, Proactive
- Computer skills (Microsoft Office)
- Internal Auditor ISO 13485:2016 Certified

**Responsibilities**:

- Develop and Coordinate Environmental and Sterilization Plans to comply with applicable regulations.
- Provide support on Environmental and Sterilization Validations, including but not limited to the development of Protocols and Reports.
- File, update, and maintain Environmental and Sterilization records in accordance with applicable regulations and licenses.
- Develop, update, and/or implement sampling plans applicable to environmental and/or sterilization processes.
- Audit Environmental, Manufacturing, and Sterilization processes.
- Coordinate and follow up on CAPAs, NCMRs, and/or Complaints related to Sterilization and Environmental, as well as the follow-up and risk management evaluation.
- Customer communication on any item related to Sterilization and Environmental issues.
- Provide support to QMS plans.
- Support all programs and initiatives related to the ethics code and Company values.
- Contribute in all safety initiatives and related programs.
- Other tasks related to the organization.

Tipo de puesto: Tiempo completo

Sueldo: $5,000.00 - $6,000.00 a la semana

Horario:

- Lunes a viernes
- Turno matutino

Puede trasladarse:

- Tijuana, B.C. (Obligatorio)

Ability to Relocate:

- Tijuana, B.C.: Relocate before starting work (Obligatorio)

Lugar de trabajo: Empleo presencial

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