Software Quality Engineering - Queretaro Site
Core
Ensure GMP compliance for non-product software systems (MES, INFOR, SAP) in a medical device manufacturing facility through validation, documentation, and regulatory adherence.
Role type
Software Quality Engineer (Regulatory/CSV)
Builds
Validated non-product software systems and quality documentation
Domain
Medical device manufacturing / Regulated industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, CSV lifecycle management, regulatory documentation, test plan creation, CAPA management, audit support, risk management, project management, data analysis
Preferred skills
SAP knowledge, Power BI, Excel, MES systems
Technologies
MES, INFOR, SAP, Power BI, Excel
Responsibilities
Implement Electrophysiology Software Quality Systems to ensure GMP compliance; Support creation of software requirements, protocols, test plans, and reports for non-product software; Identify, standardize, and document software validations to meet regulations; Provide guidance and coaching to other software quality engineers; Work with Quality, Manufacturing, IT, and Engineering to ensure compliance with quality system requirements; Coordinate and approve software requirements for CFR21, FDA, and other applicable regulations.
Seniority
Mid-level, hands-on IC
