Sterilization Microbiologist I - Impactful MedTech QA

Medtronic; Chimalhuacán; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Medtronic in Tijuana, Baja California, Mexico is seeking a Technical Specialist to advance sterilization, microbiology and analytical method development within its quality and R&D programs.

You will operate in controlled environments, apply ISO standards, validate processes, and support transfer of methodologies from R&D to manufacturing, collaborating with cross‑functional teams.

This role offers growth in a global medical device company focused on improving patient outcomes.

Formación

• Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, or a related discipline.
• Minimum of 3 years of experience within the medical device industry with knowledge of regulatory and quality system requirements.
• Solid understanding of sterilization process methodologies, including Ethylene Oxide (EtO) and radiation sterilization.
• Experience in microbiological and sterility testing methods, including Bioburden and Sterility Suitability (Bacteriostasis & Fungistasis – B&F).
• Experience performing Bacterial Endotoxin testing and microbiological laboratory analysis.
• Knowledge and hands-on experience with EO Biological Indicators, including validation, handling, and interpretation.
• Strong knowledge of international standards including ISO 14644, ISO 14698, ISO 11135, and ISO 11137.
• Experience with cleanroom technology, including airflow balancing, system functionality, and filtration systems.
• Proficiency in advanced statistical techniques for data analysis, process monitoring, and continuous quality improvement.
• Advanced English communication skills for technical documentation, reporting, and cross-functional collaboration.

Responsabilidades

• Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
• Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.
• Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
• Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
• Develops, validates, and implements controlled environment methods.
• Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
• May also be involved in establishing requirements for the transfer of methodology from R&D.

Descripción del empleo

Medtronic in Tijuana, Baja California, Mexico is seeking a Technical Specialist to advance sterilization, microbiology and analytical method development within its quality and R&D programs.

You will operate in controlled environments, apply ISO standards, validate processes, and support transfer of methodologies from R&D to manufacturing, collaborating with cross‑functional teams.

This role offers growth in a global medical device company focused on improving patient outcomes.