Software Quality Assurance Analyst IRC300107

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

Description

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

Description

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;

English

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 forefront 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.