03 oct
|
Medtronic
|
Tijuana
## Microbiologiste-Stérilisateur IPostuler: Sur site: Tijuana, Baja California, Mexico: Temps plein: Offre publiée hier: R*****Chez Medtronic, vous pouvez entamer une longue carrière d'exploration et d'innovation tout en aidant à soutenir l'accès aux soins de santé et l'équité pour tous.
Vous dirigerez avec détermination en surmontant les obstacles à l'innovation dans un monde davantage connecté et compatissant.
**Journée type** Responsibilities may include the following and other duties may be assigned.
* 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.;
**TECHNICAL SPECIALIST CAREER STREAM:**An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies.
Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
May act as a mentor to colleagues or may direct the work of other lower level professionals.
The majority of time is spent delivering R&D;, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
**DIFFERENTIATING FACTORS****Autonomy:**Entry-level individual contributor on a project or work team.
Works with close supervision.
**Organizational Impact:**Delivers work of limited scope, typically smaller, less complex projects or related activities.
**Innovation and Complexity:**Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
**Communication and Influence:**Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
**Leadership and Talent Management:**N / A – job at this level is focused on self-development.
**Required Knowledge and Experience:*** **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 *****, ISO *****, ISO *****, and ISO *****.*** **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.
**Exigences physiques du posteLes déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.
#J-*****-Ljbffr
📌 Microbiólogo-Esterilizador I (Tijuana)
🏢 Medtronic
📍 Tijuana