8 Trackwise Business Systems Analyst and Developer Jobs in Sunnyvale, CA
TalentBurst is Hiring a Trackwise Business Systems Analyst and Developer Near Sunnyvale, CA
Duration: 6 months
Contract/possibility for conversions: NA
Onsite/Hybrid/Remote: Hybrid
Only Locals/Nonlocals can be submitted: Only Locals
Mode of interview: Zoom
No of rounds of interview: 3
Job Description:
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.
Responsibilities:
1. 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.
- 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 end-users to ensure effective utilization of QMS systems.
- Troubleshoot and resolve user reported issues in a timely manner.
- 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.
- 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.
Job Summary
Full Time
$103k-126k (estimate)
05/08/2024
07/06/2024
www.talentburst.com
Framingham, Massachusetts
1,000 - 3,000
Tom Murray
<$5M
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About TalentBurst
TalentBurst, Inc. provides staffing and consulting, high hazard payroll, and managed service provider/VMS partner solutions to Fortune 1000 corporations. The company offers its staffing solutions in the areas of contract information technology, engineering, SaaS, bio-pharma, accounting and finance, marketing, utility, compliance, banking, biotechnology, healthcare, energy, government, retail, PMO, Web and infrastructure, database/data-warehousing, quality assurance, clinical, and other areas. It also provides services in the areas of health benefits, workers' compensation claims, payroll, payr...oll tax compliance, and unemployment insurance claims. The company serves customers in the United States, Canada, the United Kingdom, India, Chile, and Singapore. TalentBurst, Inc. was founded in 2002 and is based in Natick, Massachusetts. The company has branch locations in Boston, San Francisco, Miami, and Milwaukee; and international offices in Toronto, Canada; and Gurgaon and Bangalore, India. TalentBurst is a managed services provider (MSP).
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