Software Quality Assurance Analyst IRC300107

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

Software Quality Assurance Analyst IRC300107

Function

Business Process/Service Quality

Experience

5-10 years

Location

Poland

Skills

ISO 13485:2012, ISO 9001:2008, Process Control, Quality Management, Requirements analysis, Risk Management, Technical Documentation, Testing

Our client is innovative manufacturer of medical devices in the United States which produces a devices and software applications.

At this project, you will have a great opportunity to be involved into the full development life cycle of medical software which is intended to help individuals by processing certain information taken from medical devices to identify health trends and to track daily activities.

Requirements

Job Description:

• At least 2-5 years of IT industry experience (Software Quality Assurance Engineer/Analyst/process engineer or similar position from Quality Assurance or Process Management sphere) or as a quality/certification/process/metrology specialist in other domains is a must;
• Strong knowledge, deep understanding and practical application (implementation, support) of international quality management system standards and regulations (e.g. ISO 9001:2015, ISO 13485);
• Experience in auditing/assessment of Quality Management System based on international quality management system standards (e.g. ISO 9001:2015, ISO 13485, FDA Quality System Regulation (21 CFR Part 820));
• Experience in preparation / review of product-specific lifecycle documentation intended to confirm quality of the product;
• Good understanding of Risk Management principles and technics (Failure Mode and Effect Analysis (FMEA), FTA and other);
• Good understanding of medical device SQA principles and related regulations: ISO 13485, IEC 62304, ISO 14971, FDA QSR Part 820, EU MDR;
• Good understanding of software V&V methodologies and software development life cycle;
• Good understanding of software testing principles;
• Ability to work with big amounts of information, produce and organize content in a logical flow;
• Strong documentation management skills, ability to review, analyze and interpret complex and complicated documents;
• Good analytical skills;
• Attention to details and being a kind of a perfectionist;
• Ability to cope with quite routine work;
• Team player;

Upper Intermediate or higher; ability to communicate with native speakers is a must;

Job responsibilities

Leading review and approve of project documentation (such as development plans and reports, verification test plans and reports etc.), providing feedback and support team in order to ensure timely preparation and readiness of project deliverables;

Review and approve of CSV documentation;

Assessing project activities and deliverables against established procedures, standards and regulations as per established QMS;

Advising R&D team regarding implementation or adjustment of established processes;

Work closely with engineering, product, and support teams to ensure the quality and accuracy of project deliverables;

Communicating with a customer on quality assurance, process management, documentation preparation topics;

You will collaborate with R&D and product management teams to ensure robust quality processes and regulatory compliance;

This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions.

What we offer

Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people’s lives.

Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success.

DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment.

Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm.

Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment.

Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.

About GlobalLogic

GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the frontier of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.