Software Quality Engineering - Queretaro Site
Core
Ensure GMP compliance for non-product software systems in a medical device manufacturing facility.
Role type
Software Quality Engineer (CSV/GMP)
Builds
Validated non-product software systems and quality documentation for medical devices
Domain
Healthcare / Medical Devices / Manufacturing
Required skills
GMP compliance, CSV (Computer System Validation), regulatory knowledge (CFR21, FDA), software lifecycle management, CAPA, risk management, project management, data analysis (Power BI, Excel), SAP knowledge
Preferred skills
MES, INFOR
Technologies
SAP, Power BI, Excel, MES, INFOR
Responsibilities
Implement Electrophysiology Software Quality Systems to ensure business/plant continuity through GMP compliance; Support creation of software requirements, protocols, test plans, scripts, and reports to validate non-product software; Identify, standardize and document software validations to meet current regulations and medical industry standards; Provide guidance, maintain, leads and/or develops other software quality engineers in the Non product software Lifecyle; Apply the software quality methodologies to ensure that all non-product software adhere to regulations and standards; Works closely with Quality, Manufacturing, IT, Microbiology, Calibration, and Engineering on sustaining and projects activities to ensure compliance with the quality system requirements; Coordinate, approve and ensuring software requirements and compliance with CFR21, FDA and other applicable regulations
