Environmental and Sterilization Quality Engineer

Carlisle Interconnect Technologies; Tijuana; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A well-known technology company is seeking a qualified candidate to develop and coordinate Environmental and Sterilization Plans in Tijuana, Mexico. The ideal candidate will have a Bachelor's degree in Microbiology or a similar field, experience in medical manufacturing, and knowledge of relevant standards, including ISO 13485. Candidates must be bilingual in English and demonstrate teamwork and proactive skills.

Formación

• Experience in medical manufacturing environment conditions and controls.
• Knowledge of Environmental/Sterilization processes and applicable standards.
• Knowledge of ISO 13485:2016, CFR 21, Cofepris, and other applicable standards.

Responsabilidades

• Develop and Coordinate Environmental and Sterilization Plans.
• Provide support on Environmental and Sterilization Validations.
• File, update, and maintain Environmental and Sterilization records.
• Develop and implement sampling plans for processes.
• Audit Environmental, Manufacturing, and Sterilization processes.
• Coordinate and follow up on CAPAs, NCMRs, and Complaints.
• Customer communication on Sterilization and Environmental items.
• Support QMS plans.
• Contribute to safety initiatives and related programs.

Conocimientos

Teamwork

Proactive attitude

Computer skills (Microsoft Office)

Bilingual (English 80%)

Educación

Bachelor's degree in Microbiology, Biochemical Engineering, QFB, or similar

Internal Auditor ISO 13485:2016 Certified

Descripción del empleo

Job Description

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.

Requirements

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