Staff Quality Engineer - Instruments
Core
Lead quality engineering and system compliance in regulated manufacturing/validation environments to ensure product safety and regulatory adherence.
Role type
Staff Quality Engineer (Instruments)
Builds
Validated quality systems, SOPs, and compliant manufacturing processes for medical technology instruments.
Domain
Life Sciences / Medical Devices / Regulated Manufacturing
Required skills
Quality System requirements interpretation, SOP development, project scheduling, regulatory compliance, statistical data analysis, root cause analysis, audit support, quality engineering principles
Preferred skills
Advanced quality science methodologies, continuous improvement strategies
Technologies
Statistical tools, data analysis techniques
Responsibilities
Interpret and apply Quality System requirements; develop and implement SOPs and organizational policies; manage project schedules and timelines; ensure documentation compliance with regulatory standards; provide guidance on process control and supplier qualification; utilize statistical tools for root cause analysis and corrective actions; support internal and external audit activities
Seniority
Staff, hands-on IC with strategic guidance