Specialist (trackwise)

Role Overview: As a highly skilled and experienced Developer/Analyst specializing in Quality Management Systems (QMS), you will primarily focus on Java-based application development within areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. Your expertise in supporting, developing, and administering Trackwise EQMS and similar QMS will be essential for this role. Additionally, familiarity with SAP ABAP is desired to facilitate seamless interfaces between the EQMS system and SAP. Key Responsibilities: - System Support and Administration: - Provide development support for Trackwise EQMS and related QMS applications. - Administer and maintain QMS functionality to ensure optimal performance and reliability. - Requirements Gathering and Analysis: - Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities. - Analyze and translate business needs into technical specifications for system enhancements. - System Development and Customization: - Develop custom solutions and configurations to enhance QMS capabilities in various areas. - Implement interfaces between EQMS and SAP using SAP ABAP expertise. - Ensure seamless integration of QMS with other business systems through collaboration with development teams. - Quality System Compliance: - Ensure QMS systems comply with relevant regulatory requirements in the medical device industry. - Conduct audits and assessments to verify adherence to quality standards. - User Training and Support: - Provide training and support to end-users for effective utilization of QMS systems. - Troubleshoot and resolve user-reported issues promptly. - Documentation and Reporting: - Maintain comprehensive documentation for system configurations, changes, and upgrades. - Generate regular reports on system performance, issue resolution, and compliance metrics. Qualification Required: - Proven experience in Java-based application development for QMS. - Strong expertise in Trackwise EQMS and similar Quality Management Systems. - Familiarity with SAP ABAP for seamless system interfaces. - Excellent analytical and problem-solving skills. - Good communication and collaboration abilities with stakeholders and development teams. (Note: No additional details about the company were provided in the job description.),