Description
GlobalLogic is seeking a Software Quality Assurance Analyst to join a dedicated team delivering a high-fidelity medical technology platform. You will work within a highly regulated environment, ensuring that all software changes meet strict quality and safety standards.
Requirements
- At least 3 years of experience in a quality role within the medical device, aerospace/defense, automotive or similar regulated industry.
- Good understanding and practical application of medical device regulations or respective regulations in assosiated regulated industry (e.g. IEC 62304, ISO 14971 and EU MDR requirements for SaMD).
- Good understanding of Design Controls, Risk Management techniques (FMEA, FTA), Root Cause Analysis, CAPA processes, Auditing techniques (internal/external) practical application.
- Good understanding of SDLC models (Agile, Waterfall, Hybrid), Software V&V methodologies, Configuration Management principles, Change Control processes, Traceability tools/techniques.
- Good proven experience of reviewing and approving software lifecycle documentation and V&V artefacts.
- Good understanding of Computer System Validation (CSV) process and experiance in review of related deliverables.
- Good understanding of Quality Management System standards (ISO 9001, ISO13485, FDA 21 CFR Part 820 and related)
- Experience of conducting or participating in internal/external quality audits.
- Bachelor’s or Marter’s Degree in engineering field is highly desirable.
- Ability to understands and subsequently explain complex quality details to non-experts.
- Excellent written and verbal communication skills.
- Ability to work effectively cross-functionally and manage competing priorities.
- Exceptional organizational skills.
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.
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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.
