Title Specialist

Seeking a highly skilled and experienced Developer/Analyst specializing in Quality Management Systems (QMS) with a minimum of 5 years of hands-on experience supporting, developing, and administering Trackwise EQMS and similar Quality Management Systems. The ideal candidate should have expertise in Java based application development focusing on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. Proficiency in SAP ABAP is desired to facilitate the development of interfaces between the EQMS system and SAP. Responsibilities include: System Support and Administration: - Providing development support for Trackwise EQMS and related QMS applications. - Administering and maintaining the functionality of the QMS for optimal performance and reliability. Requirements Gathering and Analysis: - Collaborating with onshore teams and stakeholders to collect business requirements related to QMS functionalities, particularly in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. - Analyzing and translating business needs into technical specifications for system enhancements. System Development and Customization: - Developing and implementing custom solutions and configurations to enhance QMS capabilities in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. - Utilizing SAP ABAP expertise to support integration between EQMS and SAP. - Ensuring seamless integration of QMS with other business systems through collaboration with development teams. Quality System Compliance: - Ensuring QMS systems comply with relevant regulatory requirements in the medical device industry, especially in areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. - Conducting periodic audits and assessments to verify adherence to quality standards. User Training and Support: - Providing training and support to end-users for effective utilization of QMS systems. - Timely troubleshooting and resolution of user-reported issues. Documentation and Reporting: - Maintaining comprehensive documentation for system configurations, changes, and upgrades, specifically focused on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. - Generating regular reports on system performance, issue resolution, and compliance metrics.,