Sr Microbiologiste-Sterili Supv

## Sr Microbiologiste-Sterili SupvPostuler: Sur site: Tijuana, Baja California, Mexico: Temps plein: Offre publiée hier: R78362Chez 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 typeExperienced professional in sterility assurance, microbiology, and environmental control, with expertise in contamination control, sterilization validation, and cleanroom operations. Focused on compliance, product quality, and continuous improvement. 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.
* Coordinate the sterility assurance program by leading and supporting EO cycle qualification and requalification, radiation dose audits, EO and radiation annual reviews, and other special testing activities, such as comparative resistance studies and ethylene oxide residual testing.
* Lead and support new product transfers and introductions as the sterilization and microbiology representative.
* Conduct sterilization and microbiology impact assessments for product or packaging changes.
* Coordinate and support product release activities related to sterilization.
* Coordinate the bioburden and LAL programs to ensure control, verification, and maintenance of product families.
* Develop in-house microbiology and environmental testing techniques and coordinate activities with external laboratories.
· Support environmental control activities for cleanrooms and critical facility systems.
* Maintain risk management files related to sterilization, environmental control, and microbiology.
* Generate, investigate, and follow up on nonconformances and CAPAs related to sterilization, microbiology, and environmental control.
· Maintain trend analysis for processed loads, product damage during transit or at sterilizer plants, and sterilization process failures, and prepare associated reports.
* Review and update documentation related to sterilization processes, environmental control, and microbiology.
* Support internal and external audits related to environmental control, microbiology, and sterilization.
* Support regulatory submissions related to environmental control, microbiology, and sterilization.
* Lead or participate on projects in alignment with company optimization strategies·
* Notify actions, unsafe conditions and environmental risks observations in any of the areas of the plant.
* Manage a team of technicians and/or engineers by assigning and monitoring tasks, providing ongoing coaching and feedback, and evaluating performance PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM:Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts a