Trackwise QMS Analyst

3 weeks ago

Sunnyvale, United States Raise Full time

We’re Hiring Our key client in clinical robotics is looking for additional members for their team. We have a Business Systems Analyst III on the team.


Pay Rate: $92.59/hour on W2

Work Type: Hybrid – Sunnyvale, CA 94086 (Locals Only)

Duration: 6-month contract (with possible extension)


Key Responsibilities:


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 on time.

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.

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.


Raise PBC is committed to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religious creed, national origin, ancestry, age, disability, genetics, gender identity, veterans' status, sexual orientation, or any other characteristic protected by law. Raise PBC is an equal-opportunity employer encouraging diversity in the workplace.

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