Quality Assurance Specialist ensuring Quality Management System compliance within regulated medical device sector. Collaborating with international stakeholders to manage document control and training initiatives.
Responsibilities
Manage and continuously improve document control processes and tools within the Quality Management System
Closely cooperate with stakeholders across organizational units to ensure aligned ways of working with document control
Facilitate and coordinate training initiatives related to quality and document control across the organization
Co-responsible for EDMS (Electronic Document Management System) implementation and change control activities
Support audits and CAPA (Corrective and Preventive Actions) processes by providing structure, guidance and oversight
Collaborate cross-functionally to ensure that quality requirements are understood, documented and followed in daily operations
Requirements
have a strong quality mindset and experience working in Quality Assurance or a similar role in a regulated environment
have knowledge of ISO 13485, MDR 2017/745 and MDSAP, and a deep understanding of Quality Management Systems
are detail-oriented, structured and have strong documentation skills
communicate clearly and effectively and enjoy working cross-functionally with different stakeholders
have excellent communication and interpersonal skills, with the ability to build strong working relationships
are comfortable working in English on a daily basis
Benefits
Full-time work agreement in an international organization
Learning and development opportunities adapted to your needs and supporting your growth
Hybrid work model, combining remote work opportunities with work in an office in the Szczecin City Center
Flexible working hours
Benefits package including social benefits (private medical health care, insurance, sport card, etc.)
Scandinavian culture – informal, focused on equality, independence, open dialog, and work-life balance
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