Quality Specialist - Post Market

📋 Description

• • Embark on a career-defining journey with iRhythm Technologies, Inc., a leader in digital healthcare, and play a pivotal role in shaping the future of cardiac health solutions. As a Quality Specialist focusing on Post-Market activities, you will be instrumental in ensuring the safety, efficacy, and compliance of our innovative medical devices, directly impacting the lives of patients worldwide.
• • This role is crucial for maintaining the integrity of our product lifecycle by meticulously evaluating post-market complaints. You will be the first line of defense in assessing whether reported issues require formal reporting to regulatory bodies, adhering strictly to global standards such as 21 CFR Part 803 Medical Device Reporting and European Vigilance Reporting.
• • Your responsibilities will extend to performing and coordinating comprehensive complaint investigations. This involves collaborating closely with cross-functional teams, including Engineering, Clinical, and Regulatory Affairs, to gather all necessary information and meticulously document findings in detailed investigation reports.
• • A key aspect of this position is the technical evaluation of all complaint-related information. You will apply your analytical skills to ensure that the root cause of any reported issue is thoroughly understood, leading to appropriate corrective and preventive actions.
• • You will be responsible for ensuring that all identified issues are addressed and escalated promptly through the appropriate channels, maintaining a proactive approach to risk management and continuous improvement.
• • Maintaining an accurate and up-to-date complaints log is a fundamental duty, serving as a critical record for tracking trends, identifying potential systemic issues, and supporting regulatory submissions.
• • You will actively participate in and contribute to process improvement initiatives within the Quality and Regulatory departments. Your insights and feedback will be invaluable in refining our complaint handling procedures, enhancing efficiency, and ensuring compliance with evolving regulatory landscapes.
• • Beyond complaint handling, you will undertake other quality and regulatory-related duties as assigned, providing a broad exposure to the company's quality management system and regulatory strategy.
• • This role offers a unique opportunity to work with cutting-edge technology in the digital health space, contributing to a mission-driven organization that is dedicated to improving patient outcomes through innovative cardiac monitoring solutions.
• • You will be part of a dynamic and collaborative team, working remotely from Manila, and contributing to a company culture that values innovation, patient-centricity, and continuous learning.
• • By joining iRhythm, you are not just taking a job; you are embarking on a path to grow your skills, advance your career, and make a tangible difference in the lives of individuals globally.
• • We are seeking individuals who are curious, innovative, and possess a strong problem-solving aptitude, eager to contribute to the meaningful advancement of cardiac health and the success of our company.
• • Your work will directly support iRhythm's vision of delivering better data, better insights, and better health for all, solidifying our position as a leader in the digital healthcare industry.
• • This position requires a keen eye for detail, a strong understanding of quality principles, and the ability to navigate complex regulatory requirements within the medical device industry.
• • You will be empowered to take ownership of your work, contribute to critical decision-making processes, and see the direct impact of your efforts on patient safety and product quality.
• • The remote work arrangement from Manila offers flexibility while ensuring seamless integration into our global operations and collaborative environment.
• • We encourage a proactive approach to identifying potential risks and opportunities for improvement, fostering a culture of continuous enhancement across all post-market activities.
• • Your contributions will be vital in upholding iRhythm's commitment to excellence and its mission to transform cardiac care through technology and data.
• • This role is an excellent stepping stone for professionals looking to deepen their expertise in medical device quality assurance and regulatory affairs within a rapidly growing and impactful organization.
• • You will gain exposure to a wide range of post-market surveillance activities, contributing to the overall success and compliance of iRhythm's product portfolio.
• • The opportunity to work with a product that has fundamentally changed cardiac monitoring underscores the significance and impact of this role.
• • We are building a future where advanced cardiac health solutions are accessible to everyone, everywhere, and your role as a Quality Specialist is central to achieving this ambitious goal.
• • Join us in our quest to reimagine what's possible in healthcare and build a career that truly matters.