Quality Engineer - Querétaro Site
Core
Ensures compliance with quality system requirements and GMP/ISO standards for medical device manufacturing, supporting product validation and investigations.
Role type
Quality Engineer
Builds
Production quality compliance and validated manufacturing processes
Domain
Medical devices / Healthcare manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (FMEA), Statistical data analysis, Process validation, Root cause analysis, Six Sigma, GMP/ISO 13485 compliance, Change control, Audit support, Supervision of technicians
Preferred skills
ASQ CQE certification, Multi-departmental project leadership
Technologies
Minitab, MS Excel, MS Word, MS PowerPoint
Responsibilities
Verify adherence to Quality System and GMP/ISO standards; Assist in risk management and FMEA; Support R&D design verification and validation; Conduct NCMR, OOT, and Complaint investigations; Complete Monthly Quality Data Review; Lead Build At Risk (BAR) Authorizations; Execute IQ/OQ/PQ/PPQ Qualifications; Perform supervisor activities for Quality Technicians
Seniority
Mid-level, hands-on IC with minor mentorship
