Medical Device Software QA Analyst - Flexible Opportunities

GlobalLogic; Kraków; On-site; PLN 335,000 - 484,000; Full time

Job summary

GlobalLogic, a Hitachi Group Company, seeks a Quality Assurance professional for a medical devices project in the United States. You will contribute to the full development life cycle of medical software that processes data from devices to identify health trends.

You will lead review/approval of project documentation and CSV artefacts, ensure QMS compliance (ISO 9001:2015, ISO 13485; FDA QSR), and collaborate with R&D, product management, and engineering to support regulatory submissions and

Qualifications

• 2–5 years in IT or QA/Process role in quality or metrology.
• Strong knowledge of ISO 9001:2015, ISO 13485.
• Experience auditing QMS to ISO 9001:2015, ISO 13485, FDA QSR (21 CFR Part 820).
• Understanding of risk management (FMEA, FTA).
• Knowledge of medical device SQA regs: ISO 13485, IEC 62304, ISO 14971, FDA QSR.
• V&V and software testing fundamentals.
• Ability to manage and structure large documentation.

Responsibilities

• Leading review and approval of project documentation (development plans, reports, verification tests).
• Review and approve CSV documentation.
• Assess project activities against established procedures, standards, and regulations.
• Advise R&D on process implementation or adjustments.
• Collaborate with engineering, product, and support teams to ensure quality and accuracy of deliverables.
• Communicate with customers on QA, process management, and documentation topics.
• Contribute to robust quality processes and regulatory submissions with R&D and product management.

Skills

Quality Assurance

Regulatory Compliance

Risk Management

Documentation

SQA Principles

Software Testing

V&V Methodologies

Team Player

Auditing

Process Improvement

Job description

GlobalLogic, a Hitachi Group Company, seeks a Quality Assurance professional for a medical devices project in the United States. You will contribute to the full development life cycle of medical software that processes data from devices to identify health trends.

You will lead review/approval of project documentation and CSV artefacts, ensure QMS compliance (ISO 9001:2015, ISO 13485; FDA QSR), and collaborate with R&D, product management, and engineering to support regulatory submissions and