Quality Engineer (m/w/d)
Core
Ensure and improve product quality for life-sustaining medical devices and digital health solutions through testing, validation, and regulatory compliance.
Role type
Quality Engineer (Medical Devices)
Builds
Life-sustaining medical products and digital health solutions
Domain
Healthcare / Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Independent execution of test specifications, product release approval, CAPA management, statistical analysis of product defects, audit participation, QMS documentation maintenance, shopfloor management, operational quality problem resolution
Preferred skills
EN ISO 13485, 21CFR820, ISO 9001 knowledge, MS Office, QTrak, QDok, Minitab, Babtec CAQ
Technologies
QTrak, QDok, Minitab, Babtec CAQ
Responsibilities
Implement test specifications for in-process and final inspections, release intermediate and final products, initiate and process CAPAs, create and evaluate metrics for product errors, handle inspection plans for incoming, intermediate, and final inspections, participate in internal and external audits, maintain QMS documents, engage in shopfloor management, resolve operational quality issues in production
Seniority
Individual Contributor