Test and Validation Specialist

We are looking for a Test & Validation Specialist to support and execute Computer System Validation (CSV) activities for IT systems within our Hearing Aids business unit.
In this role, you will work closely with IT, QA, Compliance, and business stakeholders to ensure systems are implemented and maintained in a compliant state. You will be responsible for supporting validation activities throughout the system lifecycle, including documentation, risk assessments, testing, traceability, and audit readiness in line with Quality Management System (QMS) procedures and regulatory requirements.
While testing is an important part of the role, the position is primarily focused on validation, compliance, documentation quality, and maintaining validated system status in a regulated MedTech environment.

If you want to:

Work with Computer System Validation (CSV), compliance, and quality activities for IT systems in a regulated MedTech environment;
Create and review validation documentation, risk assessments, and compliance evidence required for audits and inspections;
Build and deepen your expertise in systems validation, quality, risk management, and regulatory compliance;
Collaborate with international IT, QA, DevOps, and business teams.

Working with us, you will 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 focused on equality, trust, independence, open dialogue, and work-life balance.

Apply today if you:

• Hold a Bachelor's degree (Master's degree is a plus);
• Have experience working in enterprise IT environments;
• Have knowledge of IT processes, system integrations, and end-to-end data flows;
• Have hands-on experience in Computer System Validation (CSV), qualification, compliance, quality assurance, or validation-related activities in a regulated environment;
• Have practical experience creating, reviewing, or maintaining controlled documentation such as:
• Validation Plans,
• Test Protocols,
• Traceability Matrices,
• Risk Assessments,
• Validation Reports,
• Deviations and Change Records;
• Understand the principles of Quality Management Systems (QMS) and change control processes;
• Are comfortable working in documentation-heavy environments and ensuring compliance with defined procedures and standards;
• Communicate clearly and effectively in English, both verbally and in writing

It would be nice if you:

• Have experience working in regulated industries such as Medical Devices, Healthcare, Pharmaceutical, or Manufacturing environments;
• Have experience supporting internal or external audits;
• Have knowledge of regulatory frameworks and validation standards such as:
• Computer System Validation (CSV),
• FDA 21 CFR Part 11,
• EU GMP Annex 11,
• GAMP5,
• ISO 13485;
• Have experience with validation deliverables such as URS, FS, IQ/OQ/PQ, RTM, validation reports, or deviation management;
• Stay up to date with relevant technologies, quality requirements, and industry standards.

Important to know

This is not a traditional Software Tester role.
Success in this position requires a strong focus on validation, compliance, risk management, audit readiness, and working within a Quality Management System. Candidates with experience in regulated environments and documentation-driven processes will be particularly successful in this role.

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