AQE Engineer
Core
Lead equipment and process validations (IQ, OQ, PQ), conduct quality investigations and root cause analysis, and drive continuous improvement in medical device manufacturing.
Role type
AQE Engineer (Quality Engineer)
Builds
Validated medical device manufacturing processes and compliant production lines
Domain
Medical Technology / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment and process validation (IQ/OQ/PQ), Quality investigations and root cause analysis, Supplier quality management, cGMP and ISO standards knowledge, Project leadership, Analytical problem solving
Preferred skills
Supplier quality activities, Medical device manufacturing environment experience
Technologies
IQ/OQ/PQ protocols, cGMP, ISO standards
Responsibilities
Lead and support equipment and process validations, Conduct quality investigations and root cause analysis, Support supplier quality activities and vendor audits, Analyze quality trends and drive continuous improvement projects, Partner with cross-functional teams to resolve quality concerns, Ensure compliance with cGMP and regulatory requirements
Seniority
Mid-level, hands-on IC
