- Administer and maintain the functionality of the QMS, ensuring optimal performance and reliability.
- 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.
- 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.
- 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.
- Provide training and support to endusers to ensure effective utilization of QMS systems.
- 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.
- 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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Trackwise Business Systems Analyst and Developer - Sunnyvale, CA, United States - TalentBurst, Inc.
Description
Trackwise Business Systems Analyst and DeveloperContract/possibility for conversions:
Onsite/Hybrid/Remote: Hybrid
Only Locals/Nonlocals can be submitted: Only Locals
Intuitive 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.
Provide development support for Trackwise EQMS and other related QMS applications.Requirements Gathering and Analysis:
System Development and Customization:
Quality System Compliance:
User Training and Support:
