Management Trainee, Medical Devices Complaint Investigation Specialist Role

hace 7 días


San José, San José, Costa Rica Genpact A tiempo completo

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 Management Trainee, Medical Devices Complaint Investigation Specialist roleWe are seeking a skilled and detail-oriented Medical Devices Complaint Investigation Specialist to join our team.
As a Complaint Engineer in the medical devices industry, you will be responsible for investigating and resolving complaints related to our medical devices.
You will conduct thorough analyses, identify root causes, and implement corrective actions to ensure customer satisfaction and regulatory compliance.
The ideal candidate will have a strong technical background, excellent problem-solving skills, and a deep understanding of medical devices regulations and quality standards.Responsibilities
• Receive and evaluate customer complaints related to our medical devices, ensuring timely and effective resolution.

• Conduct thorough investigations into reported issues, utilizing engineering principles and problem-solving techniques.

• Collect and analyze complaint data, product specifications, and relevant documentation to identify trends, patterns, and potential safety risks.

• Collaborate with cross-functional teams, including product development, quality assurance, and regulatory affairs, to determine root causes and implement corrective and preventive actions.
• Conduct technical tests, experiments, or simulations to replicate and understand reported issues.

• Prepare detailed investigation reports, including findings, analysis, and recommendations for corrective actions.

• Communicate with customers, regulatory authorities, and other stakeholders to gather additional information and provide updates on investigation progress.

• Ensure compliance with applicable medical devices regulations, quality standards (e.g., FDA regulations, ISO 13485), 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.
Qualifications we seek in youMinimum Qualifications / Skills
• 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.

• Proven experience in complaint investigation, engineering analysis, or a related role within the medical devices industry.

• Strong knowledge of medical devices regulations, such as FDA regulations (e.g., 21 CFR Part 820) and ISO 13485.

• Excellent analytical and problem-solving skills, with the ability to interpret complex technical data and identify root causes of issues.

• Familiarity with risk management principles, such as ISO 14971, and their application in the medical devices industry.

• Strong communication skills, both written and verbal, with the ability to effectively communicate technical concepts to non-technical stakeholders.

• 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.

• English Level C1.



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