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Trackwise Business Systems Analyst and Developer

Sunnyvale, CA 94086

Posted: 05/06/2024 Employment Type: Contract Industry: VMS Job Number: 28798

Job Description

Position Title: Trackwise Business Systems Analyst and Developer

Position Description: Protingent Staffing has an exciting contract opportunity for Trackwise Business Systems Analyst and Developer with our client located in Sunnyvale, CA.

Job Responsibilities: 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.

• 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.

Job 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.

Job Details:

• Contract: 6 months
• Pay Rate: $80 - $86 an hour
• Location: Sunnyvale, CA (Onsite)

Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

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About Sunnyvale, CA

Ready to kickstart your career in the vibrant Silicon Valley area around Sunnyvale, California? This bustling tech hub offers an unparalleled array of job opportunities in the heart of innovation. Nestled near the stunning Santa Cruz Mountains and boasting easy access to iconic landmarks like the Googleplex and Levi's Stadium, Sunnyvale provides a perfect balance of work and play. Indulge in delicious local cuisine, catch a show at the Mountain View Center for the Performing Arts, or take a stroll through the picturesque Sunnyvale Bay Trail. Don't miss out on the chance to grow your career in this dynamic and enchanting region – explore our job listings today!