Senior Quality Engineer (18 months contract)
Core
Ensuring continuous compliance with regulatory standards (FDA, GMP) across manufacturing processes and managing quality assurance for electromechanical/mechanical products.
Role type
Senior Quality Engineer
Builds
Production features (medical devices/electromechanical products)
Domain
Medical device manufacturing / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA and GMP compliance knowledge, audit execution, statistical process control, root cause analysis, supplier quality management, new product validation, inspection method design, documentation management
Preferred skills
Engineering license (EIT or PE), formal Quality Assurance certification
Technologies
Statistical process control tools, root cause analysis frameworks
Responsibilities
Conduct internal and external audits, design inspection and testing methods, stop production for non-conforming conditions, investigate product failures, collaborate with suppliers on quality issues, support new product introduction and validation
Seniority
Senior, hands-on IC