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Urgent! Environmental and Sterilization Quality Engineer Position in Tijuana - Carlisle Interconnect Technologies

Environmental and Sterilization Quality Engineer



Job description

Job Description

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


Required Skill Profession

Other Management Occupations



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