Description
RequiredBachelor of Science degree in Engineering, Computer Science or related field.6 years’ experience with quality assurance with a focus on software testing, design control of software development, software verification and validation.3 years’ experience in a quality role within the medical device, aerospace/defense or similarly regulated industry.Strong verbal and written communication skills; ability to present issues, plans and objectives.Excellent organizational, problem solving, and analytical skillsWorking knowledge of IEC 62304, FDA’s General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDR.
Requirements
- Provide Quality representation during software problem resolution.
- Participate in technical design reviews and project phase reviews.
- Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.
- Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.
- Support internal audits and external audits by regulatory agencies, as required.
Required
- Bachelor of Science degree in Engineering, Computer Science or related field.
- 6 years’ experience with quality assurance with a focus on software testing, design control of software development, software verification and validation.
- 3 years’ experience in a quality role within the medical device, aerospace/defense or similarly regulated industry.
- Strong verbal and written communication skills; ability to present issues, plans and objectives.
- Excellent organizational, problem solving, and analytical skills
- Working knowledge of IEC 62304, FDA’s General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDR.
- Ability to manage priorities and workflow Versatility, flexibility, and a willingness to work within constantly evolving priorities
Preferred
- Masters or Advanced Degree
- ASQ certification as a Software Quality Engineer or Software Quality Auditor
- Additional experience in functional areas outside of Quality (e.g. IT, Research & Development, or New Product Introduction)
Job responsibilities
- Review all project / program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
- Provides direction and leadership for verification and validation of non-product software, products software, software tools and components.
- Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation. Collaborate with project / program teams to ensure software deliverable comply with RADS procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Medical Device Regulation (MDR), and applicable guidance.
What we offer
Culture of caring.
At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you’ll experience an inclusive culture of acceptance and belonging, where you’ll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders.
Learning and development.
We are committed to your continuous learning and development. You’ll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.
Interesting & meaningful work.
GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you’ll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what’s possible and bring new solutions to market. In the process, you’ll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.
Balance and flexibility.
We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way!
High-trust organization.
We are a high-trust organization where integrity is key. By joining GlobalLogic, you’re placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.
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.
