Staff Quality Engineer - Service
Core
Developing and standardizing inspection documentation to support product quality, compliance, and operational efficiency for medical instruments.
Role type
Staff Quality Engineer (Service)
Builds
Inspection plans, work instructions, and acceptance criteria for product lines
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical documentation development, quality inspection methods, measurement systems, quality control principles, regulatory compliance translation, cross-functional collaboration, project management
Preferred skills
Medical device development experience, FDA 21 CFR Part 820 knowledge, ISO 13485 knowledge, Good Manufacturing Practices knowledge, document control systems experience, quality management systems experience
Technologies
Document control systems, quality management systems
Responsibilities
Lead development and standardization of inspection plans and work instructions, evaluate current inspection processes for gaps, translate engineering drawings and regulatory requirements into documentation, facilitate document reviews and approvals, develop templates and best practices for inspection processes, manage project timelines and stakeholder updates
Seniority
Staff, hands-on IC with strategic oversight