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Description
HYBRID POSITION - Only candidates currently residing near Sunnyvale, CA will be considered for this role. Our client is looking for a skilled Business Systems Analyst and Developer with expertise in Trackwise and Quality Management Systems (QMS). The successful candidate will have a strong background in Java development and SAP ABAP, with a focus on developing and administering Trackwise EQMS and similar QMS applications. This role will involve collaborating with cross-functional teams to gather requirements, develop custom solutions, and ensure compliance with regulatory standards. Our client is a leading provider of innovative solutions in the medical device industry. Committed to revolutionizing healthcare, they develop cutting-edge technologies that improve patient outcomes. As part of their commitment to excellence, they are seeking a talented Trackwise Business Systems Analyst and Developer to join their team for a 6-month contract.
Key Responsibilities:
Provide development support for Trackwise EQMS and related QMS applications.
Administer and maintain the functionality of the QMS to ensure optimal performance and reliability.
Collaborate with stakeholders to gather business requirements related to QMS functionalities, including Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
Develop and implement custom solutions and configurations to enhance the capabilities of the QMS.
Utilize SAP ABAP expertise to support the integration between the EQMS system and SAP.
Ensure compliance with regulatory requirements in the medical device industry, conducting audits and assessments as needed.
Provide training and support to end-users to ensure effective utilization of QMS systems.
Maintain comprehensive documentation for system configurations, changes, and upgrades.
Generate regular reports on system performance, issue resolution, and compliance metrics.
Requirements
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 in the medical device industry, with a focus on QMS.
Strong Java development skills and experience with SAP ABAP.
Expertise in Trackwise EQMS and similar QMS applications.
Excellent communication and collaboration skills.
Ability to analyze complex business processes and translate them into technical requirements.
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