Quality Systems Quality Engineer I
Core
Ensures quality compliance and process validation for pharmaceutical/medical device manufacturing facilities, managing risk, audits, and product investigations.
Role type
Quality Systems Quality Engineer I
Builds
Validated manufacturing processes, quality plans, and compliant product lines
Domain
Pharmaceutical/Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process validation (IQ/OQ/PQ), FDA regulatory compliance (cGMP/QSR), risk management (FMEA/FMECA), statistical process control, root cause analysis, metrology management, audit execution, design control
Preferred skills
Six Sigma Green Belt, ASQ/CQA/RAB certification, Health Canada GMP knowledge, analytical instrumentation expertise
Technologies
Fault Tree analysis, CpK, trend analysis, Engineering Change Orders (ECO)
Responsibilities
Develop and review quality plans and validation protocols; investigate product complaints and prepare reports; conduct internal and external audits; perform risk analysis for new product lines; manage plant metrology and calibration programs; issue stop notices for quality concerns; assist in training operators on validation and equipment
Seniority
Entry-level, individual contributor
