Microbiologist-Sterilization Eng

Medtronic México, S. de R.L. de C.V. (El Lago); Tijuana; Presencial; MXN 735,000 - 1,104,000; Jornada completa

Descripción de la vacante

A medical technology company in Tijuana is seeking a qualified engineer for a 12-month contract role in sterilization validation. The candidate should have a Bachelor's degree in Engineering, at least 3 years of experience, and thorough knowledge of microbiology and sterilization processes. Advanced English is required, and the position involves supporting compliance with regulations and performing independent work on validation cycles.

Formación

• Minimum of 3 years of relevant experience.
• Thorough knowledge of fundamental microbiology principles.
• Working knowledge of sterilization validation.

Responsabilidades

• Work independently with guidance from senior team members.
• Ensure compliance with quality requirements.
• Support execution of sterilization validation cycles.

Conocimientos

Microbiology principles

Sterilization processes

Regulatory compliance

Advanced English

Educación

Bachelor's degree in Engineering

Herramientas

MS Word

MS Excel

PowerPoint

MS Outlook

MS Project

Descripción del empleo

Responsibilities may include the following and other duties may be assigned.

Responsibilities

• Work independently with guidance and direction from senior members of the team and manager.
• Assure all quality requirements are in compliance with regulations and product specifications.
• Provide understanding of the audit process including types of audits, planning, preparation, execution and follow-up.
• Perform, coordinate, execute and summarize all areas of sterilization validation (EO, radiation, steam and chemical sterilization).
• Support the execution of sterilization validation cycles for new products.
• Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations.
• Support internal and external audits.
• Prepare written responses to regulatory questions.
• Review engineering change orders.
• Support in the resolution of non-conformances and implement corrective action.
• Work with facility maintenance and other departments for any Sterilizer and CEA improvement/corrective activities.
• Participate in special projects as assigned.
• Reviews change control notifications for impact to sterilization/microbial testing.
• Assuring that the Microbiology / Sterilization function is maintained per industry standards.

Qualifications

• Bachelors degree required (Engineer)
• Minimum of 3 years of relevant experience
• Advanced English
• Thorough knowledge of fundamental microbiology principles and bacterial lethality.
• Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project.
• 12 months contract