Quality System Engineer
Core
Ensure compliance with quality system, regulatory, and corporate requirements for manufacturing and quality records in a medical device production plant.
Role type
Quality System Engineer
Builds
Life-sustaining medical products (HD Liquid Acids, Dialysis Solutions) for export to the US and Canada
Domain
Healthcare manufacturing / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical Process Control (SPC), ISO 13485, 21 CFR Parts 210/211/820, NOM-241-SSA1, SAP/ERP systems, Quality Systems, Microsoft Office
Preferred skills
Intermediate English, Learning agility, Problem-solving
Technologies
SAP, Microsoft Office
Responsibilities
Review and disposition finished product and batch records; Monitor and control finished product lots in SAP; Verify compliance with parametric release requirements; Review environmental, water system, raw material, and manufacturing records; Review nonconformances and deviations; Administer containment hold system; Maintain Quality System procedures and Technical Archive documentation.
Seniority
Entry-level, hands-on IC
