Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000 people across 30 countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose - the relentless pursuit of a world that works better for people - we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.
Inviting applications for the role of Quality Assurance Analyst-Domain Trainee–Spanish- Hybrid San Jose
Responsibilities:
• Develop and implement comprehensive quality assurance strategies and procedures.
• Collect and analyze complaint data, product specifications, and relevant documentation to identify trends, patterns, and potential safety risks.
• Collaborate with cross-functional teams to determine root causes and implement corrective and preventive actions.
• Conduct technical tests, experiments, or simulations to replicate and understand reported issues.
• Maintain and update quality assurance documentation, including test plans, test cases and test reports.
• Participate in the design and execution of automated testing processes when applicable.
• Prepare detailed investigation reports, including findings, analysis, and recommendations for corrective actions.
• Ensure compliance with applicable medical devices regulations, quality standards (e.g., FDA regulations, ISO 13485, ISO 9001), and internal procedures throughout the complaint handling process.
• Participate in design and process improvement discussions, providing input based on complaint analysis and customer feedback.
• Assist in the development and implementation of effective complaint handling procedures and systems.
• Stay updated on industry regulations, standards, and emerging trends related to medical devices complaint handling and quality management.
• Contribute to a culture of continuous improvement and innovation within the organization.
Qualifications we seek in you
Minimum Qualifications:
· • Bachelor's degree in engineering or a related technical field (e.g., biomedical engineering, mechanical engineering, industrial engineering) is required. Advanced degree is a plus.
•Good years’ experience in quality assurance or software testing.
• Strong knowledge of quality assurance methodologies and best practices.
• Strong knowledge of medical devices regulations, such as FDA regulations (e.g., 21 CFR Part 820), ISO 13485 and ISO 9001.
• Excellent analytical and problem-solving skills, with the ability to interpret complex technical
data and identify root causes of issues. • Strong communication skills, both written and verbal, with the ability to effectively communicate technical concepts to non-technical stakeholders.
Preferred Qualifications:
• Proficient in using engineering software and tools for analysis, testing, and documentation.
• Ability to work collaboratively in cross-functional teams and manage multiple priorities in a fast-paced environment.
• Detail-oriented mindset with the ability to maintain accurate and organized documentation.
• Strong commitment to delivering high-quality products and ensuring customer satisfaction.
• Familiarity with complaint management systems and electronic quality management systems (eQMS) is a plus.
• Proficient English Level.
"The approximate monthly base compensation range for this position is CRC 1,000,000 per month The actual offer, reflecting the total compensation package plus benefits will be determined by a number of factors which include but are not limited to the applicant's experience, knowledge, skills, and abilities; geographic location; and internal equity."
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at www.genpact.com and on X, Facebook, LinkedIn, and YouTube.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.
We are inviting applications for the role of Quality Assurance Analyst-Domain Trainee–Spanish- Hybrid San Jose Responsibilities:
• Develop and implement comprehensive quality assurance strategies and procedures. • Collect and analyze complaint data, product specifications, and relevant documentation to identify trends, patterns, and potential safety risks. • Collaborate with cross-functional teams to determine root causes and implement corrective and preventive actions. • Conduct technical tests, experiments, or simulations to replicate and understand reported issues. • Maintain and update quality assurance documentation, including test plans, test cases and test reports. • Participate in the design and execution of automated testing processes when applicable. • Prepare detailed investigation reports, including findings, analysis, and recommendations for corrective actions. • Ensure compliance with applicable medical devices regulations, quality standards (e.g., FDA regulations, ISO 13485, ISO 9001), and internal procedures throughout the complaint handling process. • Participate in design and process improvement discussions, providing input based on complaint analysis and customer feedback. • Assist in the development and implementation of effective complaint handling procedures and systems. • Stay updated on industry regulations, standards, and emerging trends related to medical devices complaint handling and quality management. • Contribute to a culture of continuous improvement and innovation within the organization.
Qualifications we seek in you
Minimum Qualifications:
· • Bachelor's degree in engineering or a related technical field (e.g., biomedical engineering, mechanical engineering, industrial engineering) is required. Advanced degree is a plus. •Good years’ experience in quality assurance or software testing. • Strong knowledge of quality assurance methodologies and best practices. • Strong knowledge of medical devices regulations, such as FDA regulations (e.g., 21 CFR Part 820), ISO 13485 and ISO 9001. • Excellent analytical and problem-solving skills, with the ability to interpret complex technical
data and identify root causes of issues. • Strong communication skills, both written and verbal, with the ability to effectively communicate technical concepts to non-technical stakeholders.
Preferred Qualifications:
• Proficient in using engineering software and tools for analysis, testing, and documentation. • Ability to work collaboratively in cross-functional teams and manage multiple priorities in a fast-paced environment. • Detail-oriented mindset with the ability to maintain accurate and organized documentation. • Strong commitment to delivering high-quality products and ensuring customer satisfaction. • Familiarity with complaint management systems and electronic quality management systems (eQMS) is a plus. • Proficient English Level.
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at www.genpact.com and on X, Facebook, LinkedIn, and YouTube.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.