Specialist (trackwise)

You are seeking a highly skilled and experienced Developer/Analyst with a specialization in Quality Management Systems (QMS). With a minimum of 5 years of hands-on experience in supporting, developing, and administering Trackwise EQMS and similar QMS, your focus will be on Java-based application development in areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. Additionally, expertise in SAP ABAP is desired to facilitate interfaces between the EQMS system and SAP. Responsibilities: 1. System Support and Administration: - Provide development support for Trackwise EQMS and related QMS applications. - Administer and maintain QMS functionality for optimal performance and reliability. 2. 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. 3. 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. 4. 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. 5. User Training and Support: - Provide training and support to end-users for effective utilization of QMS systems. - Troubleshoot and resolve user-reported issues promptly. 6. Documentation and Reporting: - Maintain comprehensive documentation for system configurations, changes, and upgrades. - Generate regular reports on system performance, issue resolution, and compliance metrics.,