Business Process Analyst
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.
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.
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.
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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