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Senior Validation Engineer (Healthcare) IRC211443

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Job ID: IRC211443
Date Posted: Feb 15, 2024
Segment: Digital System & Service
Business Unit: Hitachi Services & Platforms
Company Name: GlobalLogic
Profession (Job Category): Quality Assurance
Job Type (Experience Level): Management
Job Schedule: Full-Time
Remote: Yes

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Description:

Our client is the company which produces medical software, for spinal surgery in particular. Our goal is to help our client with validation of Off-The-Shelf software tools integrated into client's SW in accordance with FDA requirements.

Requirements:

- B.S. in Computer Science, Software Engineering, Computer Engineering, or equivalent

- 6+ years of commercial quality control or/and quality assurance (at least two of them in Healthcare)

- Understanding of Validation Process

- Knowledge of Medical devices both EU MDr and FDA regulations
- Knowledge of ISO 62304
- Knowledge of ISO 14971/TC 24971
- Knowledge of FDA
- Knowledge of documenting Interfaces would be helpful, Requirements, Verification
- English - Upper Intermediate

Job Responsibilities:

- Validation of user requirements

- Tools validation

- Validation documentation creation (Validation Test Plan, Validation Test Cases, Examination Reports, Validation Test Reports)

- Communication with client

- API testing

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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