Quality Engineer - Temporary
Core
Establish and maintain Quality Systems in Europe ensuring compliance with MDD, MDR, and ISO 13485 regulations for the chemical and healthcare sectors.
Role type
Quality Systems Engineer
Builds
Quality Management Systems compliant with European medical device regulations
Domain
Chemical industry / Medical Device Regulation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality management systems expertise, MDD/MDR/ISO 13485 knowledge, CAPA program management, document and record management, audit coordination, stakeholder engagement, electronic QMS tool management
Preferred skills
Project management, chemical sector experience, ISO certification
Technologies
Electronic Quality Management Systems
Responsibilities
Manage Non-Conformity System and CAPA program, maintain document and record management systems, lead training on internal procedures, support internal/supplier/external audits, engage stakeholders on quality gaps, collect data for management reviews, coordinate enhancements of the electronic Quality Management System
Seniority
Mid-level, hands-on IC
