Senior Medical Device QA Analyst – ISO & CSV Expert

GlobalLogic; Poland; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Diversity & inclusion

Career development

Comprehensive benefits

Relocation options

Job summary

GlobalLogic is seeking a Software Quality Assurance Analyst to join our medical devices project in Poland. You will participate in the full software development lifecycle, ensuring quality across processes and documentation.

The role emphasizes risk management, regulatory awareness, and collaboration with R&D and product teams. The ideal candidate has 5–10 years in QA or quality/process fields, strong knowledge of ISO 9001/13485, FDA QSR, and software V&V.

Qualifications

• At least 2-5 years of IT industry experience in QA/Analyst roles or quality/process domains.
• Deep knowledge of international quality management standards and regulations (ISO 9001:2015, ISO 13485).
• Experience auditing QMS against ISO 9001/13485 and FDA QSR requirements.
• Experience in product lifecycle documentation to confirm quality.
• Good understanding of risk management, FMEA and FTA.
• Knowledge of medical device SQA principles and related regulations (IEC 62304, ISO 14971, FDA QSR).
• Understanding of software V&V and testing principles.
• Ability to manage large information sets and produce structured content.
• Strong documentation review and interpretation skills.
• Analytical mindset, detail-oriented, and a team player with clear communication.

Responsibilities

• Lead review and approval of project documentation and deliverables.
• Review and approve CSV documentation for compliance.
• Assess project activities against established procedures and regulations.
• Advise R&D on process implementation or adjustments.
• Collaborate with engineering, product and support to ensure quality.
• Communicate QA, process management and documentation topics with customers.
• Coordinate with R&D and product management to ensure regulatory compliance.
• Role supports patient safety, product effectiveness and regulatory submissions.

Skills

Quality Management

Requirements analysis

Risk Management

Testing

Documentation management

Software V&V

Analytical skills

Attention to details

Team player

Communication with native speakers

Tools

ISO 13485:2012

ISO 9001:2008

FDA QSR (21 CFR Part 820)

Job description

GlobalLogic is seeking a Software Quality Assurance Analyst to join our medical devices project in Poland. You will participate in the full software development lifecycle, ensuring quality across processes and documentation.

The role emphasizes risk management, regulatory awareness, and collaboration with R&D and product teams. The ideal candidate has 5–10 years in QA or quality/process fields, strong knowledge of ISO 9001/13485, FDA QSR, and software V&V.