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Senior Quality Analyst - Tool Validation IRC241724

Location: Kharkiv Ukraine
Job ID: IRC241724
Date Posted: Oct 9, 2024
Segment: Digital System & Service
Business Unit: Hitachi Services & Platforms
Company Name: GlobalLogic
Profession (Job Category): Data Analytics/Business Intelligence
Job Type (Experience Level): Management
Job Schedule: Full-Time
Remote: Yes

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Description:

GlobalLogic is a full-lifecycle product development services leader that combines chip-to-cloud software engineering expertise and vertical industry experience to help our customers design, build and deliver their next-generation products and digital experiences. We expertly integrate design, complex engineering, and agile delivery capabilities to deliver superior business outcomes for global brands in telecom, automotive, healthcare, technology, media and entertainment, manufacturing industries.

Client:

Our Client developed advanced medical technologies that were simpler, easier and safer to use. Our Client invests in research, new technologies and process improvements to stay competitive and to bring more value for the end-users. In addition, our client works with Hospitals, provides "Hospital solutions" to support end-users and staff, collect medical data, make analyzes, predict emergency cases and send data.

Requirements:

Mandatory:
• At least 4 years of commercial experience in business analysis or quality assurance or security analysis (dealing with processes and standards)
• Strong knowledge and good understanding of ISO 9001
• Strong documentation management skills;
• Knowledge of RCA techniques (FMEA, FTA, etc)
• Experience with Software Risk Management (ISO 14971)
• Intermediate-Strong level of English and good communication skills;

Preferred (would also be a plus):
• Upper-intermediate level of English and good communication skills;
• Domain expertise in Healthcare and good knowledge of ISO 13485 and IEC 62304
• Knowledge of statistics techniques
• Tool Validation

Job Responsibilities:

Responsibilities:

Controlling adhering to the project tool validation process;
Communication with a Client's representatives;
Report any gaps to the Project Manager;
Takes part in software requirements development and review;
Creation of documentation needed for the tool validation process;
Organization the project meetings and trainings if required;
Participates in the project tasks estimation;
Takes part in the Joint Review of the project deliverables;
Creates and maintains the project documentation;
Participates in the root cause analysis, impact analysis, decision analysis, and gap analysis;
Participates in the risk analysis;
Participate in solutions assessment and validation.

We Offer:
• Interesting and challenging work in a large and dynamically developing company
• Exciting projects involving newest technologies
• Professional development opportunities
• Excellent compensation and benefits package, performance bonus program
• Modern and comfortable office facilities

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 is a leader in digital engineering. We help brands across the globe design and build innovative products, platforms, and digital experiences for the modern world.

By integrating experience design, complex engineering, and data expertise-we help our clients imagine what's possible, and accelerate their transition into tomorrow's digital businesses.

Headquartered in Silicon Valley, GlobalLogic operates design studios and engineering centers around the world, extending our deep expertise to customers in the automotive, communications, financial services, healthcare and life sciences, manufacturing, media and entertainment, semiconductor, and technology industries.

GlobalLogic is a Hitachi Group Company operating under Hitachi, Ltd. (TSE: 6501) which contributes to a sustainable society with a higher quality of life by driving innovation through data and technology as the Social Innovation Business.
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