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Location

Sunnyvale, CA | United States

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Job description

VDart Inc is the leading global provider of digital solutions, products and talent management company providing digital technology solutions in Automotive, Manufacturing, Energy & Utilities and Healthcare Industries. Led by a strong global team located across 10 countries including USA, Canada, Mexico, Brazil, UK, Japan, Australia & India. We are currently accepting applications from staffing firms for our Preferred Partner Program, where we align niche staffing firms with specific verticals based on their please visit:

Trackwise EQMS Lead/QMS Technical Specialist/Trackwise Lead

CA/Sunnyvale-Onsite

6 Months

Job Description:

We are 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.
• 6. 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.

Keywords: Trackwise, EQMS, EQMS, QMS, Java, SAP ABAP

Referral Program: Ask our recruiting team about how you can be a part of our referral program. If you refer a candidate with this background and if the candidate accepts the role our team pays a generous referral. We are keen on networking and establishing a long-term, mutually beneficial partnership with you.

VDart Inc

Alpharetta, GA

Click here to Apply.

Follow us on Twitter for the hottest positions: @VDart_Jobs.

Follow us on Twitter: @vdartinc.

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