Quality Engineer 1, EU MDR
Core
Develops physical and functional test requirements, executes validation studies, and leads investigations to ensure medical device specifications and regulations are met.
Role type
Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Medical Technology / Healthcare
Required skills
Test requirement development, Protocol writing and review, Validation study execution, Complaint investigation, Risk management planning, Statistical Process Control, Sampling plan development, Design control analysis, Audit participation, Continuous improvement initiatives
Preferred skills
Engineering degree, Medical device or regulated industry experience
Technologies
Statistical Process Control, Attribute/Variable/Sequential sampling methods
Responsibilities
Develops physical and functional test requirements to assure specifications and regulations are met; Writes, reviews, and approves protocols, reports, and data; Conducts testing outlined in protocols and test methods; Executes validation studies on equipment and processes; Leads investigations related to quality problems; Develops and implements procedures to provide easy to follow instructions; Analyzes design, process, and test data; Participates in internal/external audits.
Seniority
Individual Contributor