Quality Assurance Specialist

If you want to:

Develop your expertise in Quality Management Systems (QMS) document control and regulatory frameworks in a highly regulated environment
Cooperate daily with international stakeholders across the organization and become a go-to person for quality and documentation topics
Work in an international environment with Scandinavian work culture that promotes openness trust and diversity

Apply today!

As a QA Specialist you will help ensure that our processes and Quality Management System consistently meet defined standards and regulations directly contributing to the safety and quality of our medical devices. You will focus on document control traininginitiativesand support for audits and change control working closely with stakeholders across the organization. Based in Szczecin you will be part of a hybrid team combining office collaboration with the flexibility of remote work.

Working with usYouwill receive:

• 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

What tasks are waiting for you

• 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

Apply today if You:

• 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

It would be nice if You have:

• previous experience working within the Medical Devices industry
• hands-on experience with document control requirements for Medical Devices and EDMS tools (e.g Aras Innovator D4 InfoNet)
• participated in external audits or worked with CAPA processes

We are waiting to hear from you!