Environmental And Sterilization Quality Engineer

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