Job Description :
Pay Range $80hr - $ 85hr
- Company is seeking a highly skilled and experienced Developer / Analyst specializing in Quality Management Systems (QMS).
- The successful candidate will have a minimum of 5 years of hands-on experience supporting, developing, and administering Trackwise EQMS and other similar Quality Management Systems, with a specific focus on Java based application development in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Additionally, expertise in SAP ABAP is desired to support the development of interfaces between the EQMS system and SAP.
Responsibilities :
- System Support and Administration.
- Provide development support for Trackwise EQMS and other related QMS applications.
- Administer and maintain the functionality of the QMS, ensuring optimal performance and reliability.
Requirements Gathering and Analysis :
- Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Analyze and translate business needs into technical specifications for system enhancements.
System Development and Customization :
- Develop and implement custom solutions and configurations to enhance the capabilities of the QMS in areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Develop and implement custom solutions and configurations to enhance the capabilities of the QMS, specifically in the development of interfaces between EQMS and SAP.
- Utilize SAP ABAP expertise to support the integration between the EQMS system and SAP.
- Collaborate with development teams to ensure seamless integration of QMS with other business systems.
Quality System Compliance :
- Ensure that QMS systems comply with relevant regulatory requirements in the medical device industry, especially in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Conduct periodic audits and assessments to verify adherence to quality standards.
User Training and Support :
- Provide training and support to end-users to ensure effective utilization of QMS systems.
- Troubleshoot and resolve user reported issues in a timely manner.
Documentation and Reporting :
- Maintain comprehensive documentation for system configurations, changes, and upgrades, specifically in the context of Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Generate regular reports on system performance, issue resolution, and compliance metrics.
Qualifications :
- Bachelor’s degree in information technology, Computer Science, or a related field.
- Minimum of 5 years of experience as a Developer / Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Java Development and SAP ABAP experience is essential for developing EQMS applications and interfaces between EQMS and SAP.
- Expertise in supporting, developing, and administering Trackwise EQMS and similar QMS applications.
- Strong understanding of regulatory requirements related to Quality Systems in the medical device industry.
- Excellent communication and collaboration skills for working with onshore and offshore teams.
- Ability to analyze complex business processes and translate them into technical requirements.
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